Irish PharmaChem 2016 by Retail News

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CONTENTS

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12 Investment & Development

2 Minister’s Foreword 2 Minister’s Foreword

The Government remains committed to supporting Ireland’s pharmaceutical and chemical sectors, which play a key role in the country’s economy, writes Richard Bruton TD, Minister for Jobs, Enterprise and Innovation.

4 Sector Overview Matt Moran, Director, PharmaChemical Ireland, explains how PharmaChemical Ireland itself has restructured to meet the evolving needs of the PharmaChem sector.

8 Science Foundation Ireland Science Foundation Ireland invests in research teams who generate new knowledge, leadingedge technologies and competitive enterprises in the fields of science and engineering.

12 Investment & Development The Irish biopharma sector is growing strongly and its future prospects look extremely bright. The key challenge will be to maintain a strong competitive position to support continued growth, writes Barry Heavey, Head of IDA Life Sciences, Engineering and Industrial Technologies Division.

16 Environmental Health & Safety Michael Gillen, Senior Executive with responsibility for Environmental Health & Safety, PharmaChemical Ireland, explains PCI’s position on the highly controversial endocrine disruptors.

18 Packaging Limerick Packaging have built up an enviable reputation for quality products and first class customer service, with a client base that includes some of the biggest names in the Irish pharmaceutical industry.

20 Specialised Chemicals Camida has been sourcing specialised chemicals for the life sciences, industrial and food sectors for 27 years, over which time it has developed into one of the most customer-focused and flexible companies in the industry.

22 Regulatory Science Ireland Regulatory Science Ireland is a network of interested parties, from academia to pharmaceutical companies, committed to the development of an integrated Irish response in the fields of research, education/training and knowledge sharing, to the global regulatory science effort, writes Anne Greene, Director

24 RESEARCH & DEVELOPMENT The Synthesis and Solid State Pharmaceutical centre lifted the Pharma Research Centre of the Year and Research and Development Achievement Awards at the recent Pharma Industry Awards.

26 Pharmaceutical Manufacturing and Technology Centre The Pharmaceutical Manufacturing and Technology Centre has proven itself to be a key player in the research landscape, working to achieve its vision of making Ireland a global hub of pharmaceutical process innovation.

28 Biopharma NIBRT is a world class institute, delivering training and research solutions to the global biopharma industry, writes its CEO, Dominic Carolan.

30 Counterfeit Medicines The HPRA is committed to interagency cooperation, both nationally and internationally, as it works to protect public health from the threat posed by falsified medicine products.

34 Inspections Implementing a robust GxP inspection readiness programme is essential, writes Ann McGee, MD of McGee Pharma International.

36 MATERIAL Handling Toyota Material Handling has released a complete new range of platform stackers on the European market.

PharmaChem is published by: Tara Publishing Ltd 14 Upper Fitzwilliam Street, Dublin 2. Tel: 00 353 (0)1 678 5165 Fax: 00 353 (0)1 6477127 Email: kathleenbelton@tarapublications.ie Web: www.irishpharmachem.com

Irish PharmaChem | Industry Buyers Guide 2016

Managing Director: Patrick Aylward Editorial and Marketing Director: Kathleen Belton Editor: John Walshe Advertising Sales: Brian Clark Design: Tony Hunt Production: Ciara Conway Printed by: WG Baird

39 Traceability When it comes to traceability of medicines and the Falsified Medicines Directive, your organisation needs to start preparing now, writes Siobhain Duggan, Director of Innovation and Healthcare, GS1 Ireland.

41 Recruitment Thornshaw Scientific is a leading provider of staffing, recruitment, training and outsourcing services in the pharmaceutical, medical devices, clinical research, biotechnology and related healthcare industries.

42 Supply Chain Univar Pharmaceutical Ingredients understand the importance of having access to a safe and dependable supply of quality and performance-based ingredients for your pharmaceutical formulations.

43 Contract Manufacturing B. Braun OEM Division’s expertise in contract manufacturing and infusion therapy products makes them the right partner for tailor-made solutions in the healthcare industry.

45 Stability Storage Q1 Scientific offers outsourcing of stability storage to pharmaceutical and life science companies.

46 Flow Measurement Endress+Hauser’s Proline 100 devices combine proven sensor technology with ultra-compact transmitter technologies without any compromise.

47 Bulk Packaging Versatile, cost effective and sustainable, Fibre Drums are ideal bulk packaging options for the pharma industry in Ireland.

48 Waste Management Indaver’s Total Waste Management service is designed to meet the needs of large international industrial companies, primarily from the pharmaceutical and chemical sectors.

LISTINGS SECTION

Chemical Suppliers 49 General Suppliers 51

Company Listings 57 2016 Year Planner 66 Useful References 68

Minister’s Foreword

Supporting PharmaChem’s Exciting Future Growth The Government remains committed to supporting Ireland’s pharmaceutical and chemical sectors, which play a key role in the country’s economy, writes Richard Bruton TD, Minister for Jobs, Enterprise and Innovation. As Minister for Jobs, Enterprise and Innovation, I am very pleased to provide this foreword for the Irish PharmaChem Yearbook and Directory 2016. This Government continues to be committed to ensuring the pharma sector in Ireland receives the support it needs, across the connected ecosystem of research, teaching and enterprise. The sector plays a key role in Ireland’s economy: ● Nine of the top 10 pharmaceutical and 17 of the top 25 medical technology companies have significant operations in Ireland; ● Ireland is the 8th largest producer of pharmaceuticals in the world and the world’s largest net exporter; ● Ireland exported €51.5 billion in pharma/ bio/chemistry produce in 2014, accounting for more than 50% of Irish exports by value. The industry has invested over €8 billion in the last decade and contributes total tax receipts of €3 billion annually to the Irish economy. Part of Ireland’s value proposition is its excellent and

transparent tax environment. Along with our 12.5% Corporate Tax and 25% R&D tax credit, the Government is introducing from January 1, 2016, a Knowledge Development Box that will be globally ‘best in class’ and the first OECDcompliant scheme in place.

Identifying Future Skills Around 50,000 people are directly employed in life sciences in Ireland, with an equivalent number employed in service provision to the industry. Ireland has a highly skilled, experienced workforce with strong engineering capacity and capability. However, we must guard against complacency and work together to ensure that the future skills needs of this sector are identified and actions agreed to continue to develop an experienced management and technical pool.

A Strong Research Ecosystem Ireland continues to be a key location for many of the larger industry members in the pharma

Richard Bruton TD, Minister for Jobs, Enterprise and Innovation.

“Ireland has a highly skilled, experinced workforce with strong engineering capacity and capability. However, we must guard against complacency and work together to ensure that the future skills needs of this sector are identified and actions agreed to continue to develop an experienced management and technical pool.”

Irish PharmaChem | Industry Buyers Guide 2016

Minister’s Foreword “During 2014, NIBRT provided ‘real-world’ training to over 3,200 people in the industry and continues to go from strength to strength, with the provision of core funding through IDA Ireland announced as part of the Action Plan for Jobs 2015.”

sector, with an extremely strong regional spread and IDA Ireland is continuing its programme of investment in advanced property solutions. Our indigenous life sciences sector now consists of over 250 Enterprise Ireland client companies. We have a strong, established collaborative research ecosystem – involving industry, academia, researchers and Government. The opportunity for Ireland here is great, not only in terms of the economic benefits, but also in terms of the hugely significant societal benefits associated with R&D. Last year, my Department established the Horizon 2020 Strategic Research Proposals Group to identify large-scale funding opportunities for businesses and researchers in Ireland and to nurture applications that will give big wins for Ireland. I would encourage companies to look at the opportunities and work with us to secure our ambitious national target of €1.25 billion in EU funding. The Government has put in place the infrastructure of SFI research centres, EI and IDA technology centres and of course NIBRT, which was established by the Government to support the biopharmaceutical industry in Ireland by

Irish PharmaChem | Industry Buyers Guide 2016

educating and training highly skilled staff and by conducting research in collaboration with industry. During 2014, NIBRT provided “real-world” training to over 3,200 people in the industry and continues to go from strength to strength, with the provision of core funding through IDA Ireland announced as part of the Action Plan for Jobs 2015.

Innovation Showcase Last year, over 1,700 people attended the first national Innovation Showcase, which provided a major boost to the national effort to enable commercial collaborations between industry and research teams in HEIs. This year’s Innovation Showcase was held on December 8 in the Convention Centre, Dublin, and provided a great opportunity to engage with the public research community in Ireland. I look forward to continuing to work with the Pharma Sector and I wish the Irish PharmaChem Yearbook every success in the year ahead.

Richard Bruton TD, Minister for Jobs, Enterprise and Innovation

Sector Overview Matt Moran, Director, PharmaChemical Ireland, explains how PharmaChemical Ireland itself has restructured to meet the evolving needs of the PharmaChem sector.

Growing with the Industry In my article last year, I wrote at some length around how the sector here continues to respond in a very positive way to the post patent cliff environment. In fact, since I penned that piece, the stream of new investments has continued more or less unabated. Alexion confirmed that they will be investing some €450 million in a new biologics facility in Dublin. Bristol Myers Squibb has commenced construction of a €700 million biologics facility across the road from Alexion. They will be joined by Mallinkrodt Medical, who are also constructing a brand new biologics facility in Cruiserath, making it one of the largest biotech clusters in the country; not too far from the Pfizer biotech facility at Grangecastle, who announced recently that they plan to invest $330 million and create a further 130 jobs across all their facilities in Cork and Dublin. We have also witnessed the emergence of a number of virtual or supply chain models in Ireland, such as Horizon Pharma, based in Dublin, helping to make Ireland one of the major global hubs for the supply of biopharmaceutical products globally.

Continued Evolution of the Sector We are witnessing the continued evolution of the sector in Ireland. With this evolution, we see much more diversification within the

sector. This is all positive news for Ireland, as with diversity comes a more sustainable sector. However, this evolution and diversity presents a fresh set of challenges for the sector. PharmaChemical Ireland (PCI), being the primary representative body for the sector, set about examining its own structure to ensure that it was fit for purpose in assisting the sector to meet all of its needs and challenges. From PCI’s perspective, it has always been important that we reflect the needs of our membership as effectively as possible. In many ways, the members view PCI as being a reflection of the companies themselves. Hence, PCI operates a significant number of working groups or expert networks which have provided an invaluable service to member companies, generating a level of cooperation which is quite unique to this country. However, as the industry becomes more diverse, the membership of PCI were keen to ensure that this diversity was reflected at a high level within its own organisational structure. The PCI membership embarked on an intensive strategic review in 2014 to address this issue. The challenge was how to enhance its strategic role without losing the value generated via its expert groups, often referred to as the engine of the organisation. The membership of PCI spent over a year engaged in extended workshop driven discussions in order to consider these Irish PharmaChem | Industry Buyers Guide 2016

Sector Overview issues in the necessary detail required. Former CEO of Genzyme-Sanofi (subsequently appointed as CEO of NIBRT), Dominic Carolan provided external support to the process. A detailed membership survey supported the entire exercise. It became clear to the membership that there was a need to maintain the strategic focus of PCI, especially on the external environment, both national and international. It also became clear that it was important that the association stay relevant across all sub-sectors within the industry.

The new structure of PharmaChemical Ireland.

New Structure of PCI Two decisions were proposed to the membership at the workshop late last year. One was to establish a Board for PCI and the second was to set up a number of industry platforms. The primary purpose of this was to give the industry a strong advocacy platform and to in turn give each sub sector their own platform. Each of these platforms would in turn be represented on the main board of PCI, where they would also have the opportunity to collaborate across the various platforms. The industry concluded that there was strength in unity and that this would be the most effective way to advance the industry as a whole. The new structure has been operating successfully since February of his year. Already, a number of common themes have emerged: ● the need to supply adequate skilled talent to supply a sector that is expanding rapidly as a result of significant capital investment, especially in the biologics area; ● the need to profile and project a life sciences cluster nationally and internationally; ● the need to continue to invest in innovative activities to embed the sector in the country. These are recurring themes that have always underpinned the success of the sector here in Ireland. The rapid growth of the sector has served to bring them into ever sharper relief.

The Latest Developments Already the board of PCI has responded by: ● approving the establishment of a PCI sponsored skillnet to support the provision of courses to help supply the talent pipeline - PCI is utilising the existing PharmaChem skillnet that is based in Munster. ● approving the preparation of Phase 4 of an industry strategy for the country. This will be launched in March of 2016 at the DCAT meeting in New York . This will help to raise the profile of the sector both globally and nationally. ● approving the hosting of a major Biopharma event in September of 2016 in collaboration with The Irish Pharmaceutical Healthcare Association (IPHA ). This will profile the sector from research through to the marketplace, emphasising the enormous Irish PharmaChem | Industry Buyers Guide 2016

Sector Overview Continuing the Innovation Journey Throughout the Lifecycle was the title of the fifth biennial PCI conference, held in Cork in September 2015.

CONTINUING THE INNOVATION JOURNEY THROUGHOUT THE LIFECYCLE

ifth Biennial PharmaChemical Ireland/PDA/ISPE Quality and Innovation Conference 3 & 24 September 2015 Radisson Little Island, Cork

association with

DRIVING THE INDUSTRY FORWARD

Fifth Biennial PharmaChemical Ireland/PDA/ISPE Quality and Innovation Conference 23 & 24 September 2015 Radisson Little Island, Cork

ponsored by In association with

Sponsored by

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contribution that the sector makes to the economy here and also its central role in enhancing people’s lives from now into the future. In recognising the need to promote and support the establishment of a strong industry cluster in the country, the Board has supported opening up the membership of PCI to associate members. The primary purpose of it is to reach out to the industry’s partners and stakeholders in a more structured and inclusive way, with a view to enhancing the depth and scope of the sector here. PCI is also very keen to support the growth of indigenous companies here, both in Biopharma and chemical manufacture, as well as supply to the sector through products and services. Those interested in hearing more about this should contact me.

PCI Conference: Continuing the Innovation Journey Throughout the Lifecycle In September of this year, PCI hosted its fifth biennial conference in collaboration with The Parenteral Drugs Association (PDA) and the International Pharmaceutical Engineers (ISPE) in Cork. The title of the conference was ‘Continuing the Innovation Journey Throughout the Lifecycle’ and the event attracted 200 delegates from Ireland and overseas. The conference was addressed by an impressive range of national and international speakers drawn from the regulatory bodies and the industry. As ever, the HPRA provided excellent support for the event and the industry appreciated the opportunity to interact directly with the regulator. Delegates were briefed on the latest ICH Guide, Q12 that deals directly with Lifecycle Management, by the guide rapporteur, Moheb Nasr of GSK. The range of topics addressed was as broad as ever, from Tim O’Brien describing Mensenchymal Stem Cell Manufacture, through the latest trends from the FDA to a Kaizen Workshop hosted by Richard Keegan of Enterprise Ireland. Delegates were able to join a number of exhibitors for networking and knowledge sharing right the way through the event. Delegate feedback was very positive. Thanks to conference sponsors, Hovione, Indaver, MSD and Life Sciences Consultants. In conclusion, this has been a very busy period for the industry and for PCI. It is likely that this will continue for the foreseeable future as we grapple with the challenges that rapid growth present. However, I am confident that we can and we will meet these challenges now and into the future.

Irish PharmaChem | Industry Buyers Guide 2016

Global. Diversified. Transformative.

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. Headquartered in Dublin, Ireland, Alkermes has its principal solid oral pharmaceutical development and manufacturing facilities in Athlone. Located on a 40 acre site, capabilities include formulation development, analytical development, tech transfer, product scale-up, product registration and commercial manufacturing.

www.alkermes.com

Irish PharmaChem | Industry Buyers Guide 2016

Award Winner 2012

Science Foundation Ireland

Investing in the Future Science Foundation Ireland (SFI) invests in research teams who generate new knowledge, leading-edge technologies and competitive enterprises in the fields of science and engineering. Ireland is building a reputation as a world leader in scientific research capability, continuously climbing the international citation and innovation rankings to be 16th in the global rankings for citations, while achieving rankings of first in Nanoscience, second in Immunology and Computer Science, third in Animal and Dairy, and fifth in Material Sciences research. Ireland is committed to funding excellent and impactful research. SFI supports over 450 leading researchers, who are involved in over 1,200 collaborations with industry: 650 with multinational companies and 560 with SMEs. SFI research teams are engaged in 1,843 international collaborations across 57 countries.

The SFI Strategy: Agenda 2020 Agenda 2020, SFI’s ambitious seven-year strategic plan, lays out four key goals, the

strategies for achieving them, and the performance indicators that will be used to measure SFI’s progress. SFI’s four goals are: 1. To be the best science funding agency in the world at creating impact from excellent research and demonstrating clear value for money invested. 2. To be the exemplar in building partnerships that fund excellent science and drive it out into the market and society. 3. To have the most engaged and scientifically informed public. 4. To represent the ideal modern public service organisation, staffed in a lean and flexible manner, with efficient and effective management. In the Agenda 2020 document, each of these objectives is elaborated upon by setting out the reasons why it is important, the actions

that will be taken to achieve it and the KPIs that will be used to measure progress. Each year, SFI publishes both an audit of progress and an annual plan.

Priorities for the year ahead include: ● Empower Irish researchers to lead and win

in the EU Horizon 2020 programme; ● Assess and fund new Spokes projects,

jointly with industry, to existing SFI Research Centres; ● Assess and fund new SFI Research Centres, jointly with industry; ● Support the development of early and midcareer researchers; ● Provide funding in significant partnership with industry or major research entities, in areas of strategic national importance; ● Provide funding to promote the study of, education in and awareness of science, technology, engineering and mathematics (STEM).

SFI Research Centres There are now a total of 12 world-leading Science Foundation Ireland Research Centres, each of a scale spanning several Higher Education Institutions and collaborating with industry. SFI has committed to invest over €355 million in the 12 SFI Research Centres, with a further €190 million from industry collaborators. The centres have over 200 industry partners and focus on strategically important areas for Ireland.

Irish PharmaChem | Industry Buyers Guide 2016

Science Foundation Ireland SFI Research Centres linked to pharma-related investments include: ● The Alimentary Pharmabiotic Centre (APC),

led by Prof. Fergus Shanahan at APC and with co-investigators in UCC, Teagasc Moorepark Food Research Centre, Mercy University Hospital, Cork University Hospital and Cork Institute of Technology, investigates the close links between diet, the microbiota and health status. The Centre aims to provide the necessary scientific basis for the selection of healthpromoting bacteria and food constituents for incorporation into ‘functional foods’ for improved health, and which can support the development of novel bioactives to treat intestinal and infectious diseases. The research undertaken by the APC will address important societal issues, such as disease prevention, improved cognition and healthy ageing, and is supported by food, biotechnology, pharmaceutical and diagnostic industries. ● INFANT, Irish Centre for Fetal and Neonatal

Translational Research, is led by Prof. Louise Kenny and Prof. Geraldine Boylan at UCC, with co-PIs based in Tyndall National Institute at UCC, Royal College of Surgeons (RCSI). The INFANT team is a diverse group of doctors and scientists who are supported by strong industry partners, international collaborators and business and regulatory advisors. Over the last five years, the team has collaborated to develop screening and diagnostic tests and novel methods of monitoring pregnancy and newborns and the team members have become international leaders in this area. INFANT will focus on fasttracking discoveries to the bedside by serving as a hub for innovation, spanning three of the major priority areas outlined in the Research Prioritisation Report: Diagnostics, Medical Devices and Connected Health. These areas are associated with large global markets that have a strong Irish base. ● The Synthesis & Solid State Pharmaceutical

Centre (SSPC) is led by Prof. B.K. Hodnett. The overarching aim of the SSPC Centre will be to better understand mechanisms, control processes and predict outcomes for the efficient and environmentally sustainable production of safe medicines. This will be achieved by utilising a “molecule-to-medicine” approach that encompasses chemical synthesis, crystal engineering, and drug production and manufacture. A total of 19 individual projects will be carried out, which all fall under one of three main themes: 1. New Frontiers in Pharmaceutical Synthesis: efficient synthetic routes and processes for molecules that are precursors to potential pharmaceutically relevant materials; Crystal Growth and Design: studying 2. the physical characteristics of crystalline materials and their interactions to understand how to utilise them most effectively as active pharmaceutical ingredients; Irish PharmaChem | Industry Buyers Guide 2016

3. Drug Product Formulation and Manufacture: using science- and engineeringbased knowledge to optimise solid state pharmaceutics and produce new and improved drug formulations.

Key Programmes of Interest to Industry SFI supports the development of strategic partnerships to deliver ground breaking scientific research for the competitive advancement of Ireland. SFI has different funding levels and programmes that suit industry informed research and academic industry interactions at a number of levels: SFI Industry Fellowships: The purpose of the Industry Fellowships Programme is to facilitate the placement of researchers in industry or academia to stimulate excellence through knowledge transfer and training. Fellowships will enable access for researchers to new technology pathways and standards and will facilitate training in the use of specialist research infrastructure. Fellowships can be awarded to academic researchers wishing to spend time in industry worldwide or to individuals from industry anywhere in the world (including Ireland) wishing to spend time in an eligible Irish research body. Funding of up to €120,000 direct costs per fellowship is available. Science Foundation Ireland Partnerships: The SFI Partnerships Scheme provides a flexible mechanism by which key partners such as companies, funding agencies, charities, philanthropic organisations or research bodies can partner with the goal of co-funding outstanding research opportunities in Ireland. The scheme provides an opportunity for industry to engage with world class academic researchers and have access to infrastructure and intellectual property, using a shared risk funding model in which SFI matches the investment made by industry. A key feature of the Partnerships Scheme is the recognition that collaboration with industry must be responsive and flexible. For this reason, the scheme employs adaptive partnership models that have been developed to meet industry partner needs or specific industry challenges. For example, through the Competitive Partnership Programme, SFI partners directly with industry to launch a competitive call for proposals to address key research priorities or challenges and identify academic partners of interest to the company. The Strategic Partnership Programme supports more targeted collaborations between industry and academic research groups (i.e. a company has identified a specific academic group with which it wishes to collaborate with, prior to application) through a non-competitive, fast track, international peerreview process. Science Foundation Ireland Research

Science Foundation Ireland

SFI Partners with AbbVie At the Global Irish Economic Forum in Dublin Castle, Minister for Jobs, Richard Bruton TD announced a joint investment of €10 million by SFI in a partnership with leading international biopharmaceutical company AbbVie to undertake two new therapeutic research collaborations in Ireland. The collaborations, which will each investigate disease markers and potential targets against which new drugs could be developed for serious illnesses such as Crohn’s disease, rheumatoid arthritis, psoriasis and multiple sclerosis, are between AbbVie and researchers at the SFI APC Microbiome Institute in University College Cork (UCC) led by Prof. Fergus Shanahan and at the Trinity Biomedical Sciences Institute in Trinity College Dublin led by Prof. Kingston Mills. Pictured at the announcement are Prof. Mark Ferguson, Director General, Science Foundation Ireland and Chief Scientific Adviser to the Government; Minister for Jobs, Enterprise and Innovation, Richard Bruton TD; and Jim Sullivan, Ph.D., Vice President, Pharmaceutical Discovery, AbbVie.

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Centres: These are world-leading, large-scale research centres with a major economic impact for Ireland. They consolidate research activities across higher education institutes to create a critical mass of internationally leading researchers in strategic areas which will lay the foundation for effective and productive academic and industrial partnerships. SFI Research Centres can receive €1-5m a year in direct costs. SFI funds up to 70% of the overall research centre budget. A minimum of 30% of the budget must be secured from industry partners, at least one-third of which must be cash. New industry partners are always welcome to join Science Foundation Ireland research centres and are encouraged to contact centres of interest directly. Science Foundation Ireland Research Centre Spokes: The SFI Spokes Programme provides additional funding opportunities for companies to engage in collaborative research projects of scale with SFI Research Centres. The Programme includes both a competitive Fixed Deadline and a non-competitive Rolling Call (applications can be submitted to the Rolling Call at any time). For more information about SFI-supported research and details of upcoming calls, go to www.sfi.ie. Irish PharmaChem | Industry Buyers Guide 2016

At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives.

For further information please contact Roche Ireland Limited Clarecastle Co. Clare Tel: (065) 686 7200 Irish PharmaChem | Industry Buyers Guide 2016

Investment & Development Barry Heavey, Head of Life Sciences, Engineering and Industrial Technologies Division, IDA.

Maintaining the Momentum The Irish biopharma sector is growing strongly and its future prospects look extremely bright. The key challenge will be to maintain a strong competitive position to support continued growth, writes Barry Heavey, Head of IDA Life Sciences, Engineering and Industrial Technologies Division. Last year, we described how the Irish biopharma sector had turned a corner and returned to growth, following a number of years of challenges. 2015 saw continued growth and a number of new investments, auguring well for the future

Drivers of Employment Growth Biopharmaceuticals remain a key source of growth for the industry and 2015 saw that trend continue with new investments in biologics manufacturing announced from BMS ($900 million), Alexion ($450 million) and a major expansion from Regeneron ($350 million). A recent survey by IDA of senior leadership in the industry suggested that there remains a strong pipeline of new biologics that will require additional investment in new manufacturing capacity in the coming years. This creates additional investment opportunities for Ireland to compete for. Many companies are considering a variety of options, including investment in traditional manufacturing capacity (based on stainless steel), while others are considering investment in factory of the future concepts (with increased use of disposables). Many companies are also establishing or considering strategic links with contract manufacturing organisations. Irish PharmaChem | Industry Buyers Guide 2016 12

IDA have placed strategic focus on trying to win investment from a major CMO in the biotech space in the coming years in order to maximise our competitive position in this growing market. Another trend noted last year was continued in 2015 with the generic company Amneal joining major players such as Teva and Mylan by investing in drug product development and manufacturing, particularly in the area of drug-device combinations. This continued investment by generics companies underlines Irelandâ&#x20AC;&#x2122;s ability to compete on cost and regulatory excellence with other low cost locations.

Skills Availability The biopharma subsector is approaching 6,000 in direct employment: high value jobs in diverse regional locations. These new jobs in biopharma companies have also helped in delivering thousands of high value jobs in the construction and associated services involved in delivering these greenfield and expansion investments. With previously announced investments nearing completion and coming onstream (from Lilly, Grifols, Allergan, Regeneron, Sanofi) and a healthy pipeline of projects in play to be won, it is possible that

direct employment in biotech manufacturing will approach 8,000 in the coming years. With this in mind, the availability of skilled labour will be a key factor in maintaining the momentum that has been achieved to date. The overall pool of skilled workers must be grown to ensure that Ireland has the capacity to deliver these investments and avoid a situation where a war for talent results in loss of competitiveness in wages and turnover rates. NIBRT is on target to provide training to close to 4,000 people in 2015 and NIBRT works collaboratively with universities and institutes of technology across the country. This represents a mixture of pre-hire training for undergraduates and job seekers, with funding from agencies such as HEA/Springboard and Skillnets, and post-hire training, funded by employers. A key focus for 2016 and onwards will be to ensure that there is continued growth in the funding available for pre-hire training of job seekers to grow the pool of talent in the industry. The depth of pre-hire training provided to job seekers will be key to the success of such initiatives. If trainees can gain sufficient experiential learning with exposure to facilities and equipment that mimic a GMP environment, then they will be more attractive to potential employers.

Challenges and Opportunities in Small Molecule Manufacture Small molecule manufacturing (both API and traditional oral solid dose) continues to Irish PharmaChem | Industry Buyers Guide 2016 15

Irish PharmaChem | Industry Buyers Guide 2016

160870 IDA Pharma Year Book A4_p.indd 1

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Investment & Development face challenges and has seen a decrease in employment from 15,000 direct employees in 2007 to 12,500 in 2011. Employment numbers have stabilised in recent years and a number of sites have achieved major turnarounds. Pfizer’s Little Island facility had been ear-marked for closure/divestment but this year, the company announced that they would maintain production at the site. A number of companies have also been investing in new technology such as high containment, small batch production, novel synthetic pathways (including biocatalysis) and some investment in continuous manufacturing. This year, IDA approved more R&D and training grant support for the small molecule sector than was approved for biopharma investments. Likewise, SFI and EI have invested heavily in research centres that support the small molecule industry, such as SSPC and PMTC. This is evidence of Government’s continued commitment to supporting the sector and fits with the continued opportunities globally, with a number of high profile approvals of small molecule drugs in areas such as cancer and infectious disease. However, challenges undoubtedly remain and as additional sites (such as MSD’s Rathdrum facility) wind down towards closure, maintaining employment in this sector will require continued efforts from all stakeholders: Government, management and workforce.

Services-based Employment Services based jobs are making up an increasing proportion of the workforce in the multinational biopharma sector. More traditional services roles, such as finance, CMC regulatory affairs and supply chain management, are now being supplemented by newer roles in areas such as medical regulatory affairs, medical writing, digital content development, data analytics and clinical trial management. Parexel have joined the growing cluster of

contract research organisations based here in Ireland, along with PPD, Quintiles, Eurofins and Icon. These types of investments ramp up to employment quickly and Ireland’s track record in delivering large numbers of skilled, flexible and multilingual workers for the tech sector is very compelling for companies considering Ireland for highly technical services roles. The Shared Services forum remains a key networking event to bring companies from different sectors together to share experiences in establishing shared services investments in Ireland.

Maintaining Our Competitiveness Ireland has an excellent track record in biopharma manufacturing and continues to win a large share of mobile foreign direct investment. Our competitive position in all sectors has improved dramatically since 2008 but it is vital that we now hold onto the hardwon gains in competitiveness in the biopharma industry. With strategic sites manufacturing high value products, it is always possible to lose sight of issues such as cost competitiveness, operational excellence and flexibility/ adaptability. Management and workers need to collaborate to benchmark site performances against international competition and work to ensure the long-term viability of the Irish sites. A key element of this will be to be constantly conscious of and plan for the “patent cliffs” of the future. Government has a role to play to supporting companies investing in training and upskilling to drive operational excellence. Much can be learned from the medical device industry, another high margin, highly regulated manufacturing sector, but one where the innovation cycle is much shorter. This shorter innovation cycle means that companies and their products lose exclusivity in the market rapidly and regularly and companies must plan for continuous margin erosion. The

Irish PharmaChem | Industry Buyers Guide 2016

Investment & Development

Irish sites of companies like DePuy, Abbott and Lake Region have all recently won International Shingo awards for operational excellence and employee engagement and the Irish Medical Device Association has worked closely with companies to support these competitiveness initiatives

Investing in R&D IDA’s strategy, Winning FDI 2015-2019, outlines a plan to support clients in creating 80,000 new jobs in all sectors and increase employment in the client portfolio to 209,000 by 2019. Support for R&D will be key to achieving these targets. The biopharma sector is one of the most active sectors in terms of R&D investment and utilisation of IDA RD&I supports. Direct financial support for RD&I from IDA to our client companies can: ● Help to attract new, innovative & R&Dintensive companies with new high value products/services who are considering investment in multiple locations;

Irish PharmaChem | Industry Buyers Guide 2016

● Support continuous development/ expansion of existing R&D-intensive clients, who must continuously compete with sister sites to be the location of choice for development and commercialisation of the most valuable products and services in the company’s pipeline; ● Support transformation and prevent job losses in existing client companies who are facing severe competitive pressure and potential closure. R&D may support improvements in productivity, develop a strengthened reputation for quality or to develop new products and services. Direct Government support for applied RD&I investment in these companies can be a key factor in winning buy-in from company HQ to maintain the Irish operation. IDA also sees significant potential for promoting business to business collaboration, between indigenous and MNC companies and between MNCs in the same of different sectors. Keys areas of focus in the biopharma space

would include: ● Collaboration with medical device and ICT companies on next generation drug delivery devices; ● Collaboration with technology and engineering companies on factory 4.0 for biopharma (sensorised factories, disposable manufacturing systems, continuous manufacturing, PAT, and advanced automation); ● Collaboration between small molecule and biologic sites on antibody drug conjugates and gene therapy.

R&D investment in some or all of the areas above can grow the Irish biopharma cluster and assist in achieving targets for new job creation and minimisation of job losses. IDA’s RD&I grant program has been shown by an independent study conducted by Forfas to have economic value add of €25:1 over a 10-year horizon. IDA remains committed to driving further increases in business expenditure in R&D and utilising our grant budget to maximise this.

ENVironmental Health & Safety

Endocrine

Disruption: Where Do We Stand?

There is mounting concern about the possible negative effects of so-called endocrine disruptors on human health and the environment. These endocrine disruptors are chemicals that can interfere with the endocrine (or hormone) system in mammals when ingested at certain doses. PharmaChemical Ireland is committed to ensuring that people and the environment are properly protected from harmful exposure to chemicals. We want to see endocrine-affecting substances, if found to be harmful, properly regulated. Back in June 2014, the European Commission published a roadmap that had the following objectives: ● ensuring a high level of protection to human health and the environment; ● strengthening the functioning of the internal market; ● providing for legal clarity, predictability

and coherence in the identification of ED;

● providing for scientific criteria that are operational in terms of regulatory decision-making; ● ensuring possibility to apply these criteria across all relevant Union legislation.

The Options Arising from this, four options, defining possible criteria, were proposed. These were: Option 1: No policy change (baseline). No criteria are specified. The interim criteria set in the Biocides Product Regulation (EU) 528/2012 (BPR) and the Plant Protection Product Regulation (EC) 1107/2009 (PPPR) could continue to apply. Option 2: WHO/IPCS definition to identify endocrine disruptors (hazard identification).

Michael Gillen, Senior Executive with responsibility for Environmental Health & Safety, PharmaChemical Ireland, explains PCI’s position on the highly controversial endocrine disruptors.

Option 3: WHO/IPCS definition to identify endocrine disruptors and introduction of additional categories based on the different strength of evidence for fulfilling the WHO/IPCS definition. Option 4: WHO/IPCS definition to identify endocrine disruptors and inclusion of potency as element of hazard characterisation (hazard identification and characterisation). PharmaChemical Ireland favoured option four of the Commission’s roadmap for defining criteria, but with additional elements of hazard characterisation to be incorporated into the ED criteria, namely severity of effect, (ir)reversibility of effect, potency and lead toxicity. We consider potency, a fundamental and well-established principle of toxicology, as a key element for the identification of endocrine disruptive substances of regulatory concern. Ignoring potency could lead to the prohibition of many synthetic substances that are no more Irish PharmaChem | Industry Buyers Guide 2016

Environmental Health & Safety harmful than everyday plant-based foods such as grains, vegetable and fruits. A threshold – the level at which exposure to a substance is considered safe for human health and/or the environment – should be determined for endocrine disruptive substances (on a case-bycase basis) and should be used in the regulatory context. A regulatory threshold is several times lower, thereby building in additional margins of safety, which means that exposure to endocrine disruptive substances can be considered safe for human health and/or the environment.

Existing Legislation Endocrine disruptors are already addressed by the current strict EU regulatory framework, in a number of legal instruments such as REACH (Regulation on the Registration, Evaluation and Assessment of Chemicals), the Water Framework Directive, the Biocides Directive and the Pesticides Regulation. This legislation, applying to all chemical substances, ensures that chemical products placed on the market are safe. We believe that is no legal vacuum where endocrine disruptors are concerned. It’s a matter of determining together, public authorities, the scientific world, industry, competent independent agencies and civil society, the most appropriate criteria for defining what is, and what is not, an endocrine disruptor. In REACH, endocrine disrupting chemicals are considered of similar regulatory concern as other substances of very high concern. The European Commission is currently delivering on its obligation to propose appropriate science-based criteria for identifying endocrine disruptors that require regulatory action.

EU Public Consultation Process Following on from the roadmap above, the Commission held a public consultation with stakeholders, and is now analysing the input received. The Irish pharmachemical industry provided its input to the consultation via Cefic. While fully supporting the European

Commission in its initiative, PharmaChemical Ireland is concerned that the Commission comes up with a workable definition of an endocrine disruptor, acknowledging potency thresholds and the severity of effects. We have long been asking for regulation to be based on science, to avoid restrictions on chemical substances that would lead to the loss of useful products with no gain in chemical safety for people or the environment. The Commission is also carrying out two studies. The first one assesses substances individually to determine which substances are characterised as endocrine disruptors by each of the four sets of criteria. The second study assesses the consequential socio-economic impact. We expect these studies to be published towards the end of 2015 and 2016 respectively. Following further evaluations and discussions, the Commission should come forward with a proposal for criteria towards the end of 2016.

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The International View Endocrine disruptors are also addressed at an international level, where the International Council of Chemical Associations (ICCA) plays an active role. The OECD is developing test methods and guidance for the assessment of endocrine disruptors. In the context of the United Nations Environment Programme (UNEP), the Strategic Approach to International Chemicals Management (SAICM) in ICCM3 identified endocrine disrupting substances as emerging policy issues, agreeing to implement cooperative actions to increase awareness and understanding amongst policy makers and other stakeholders. PharmaChemical Ireland, in conjunction with Cefic, will continue to contribute its expertise to the work of the European Commission, OECD and EU member states, in developing a framework for systematically identifying substances with endocrine disruptive properties.

“We consider potency, a fundamental and well-established principle of toxicology, as a key element for the identification of endocrine disruptive substances of regulatory concern. Ignoring potency could lead to the prohibition of many synthetic substances that are no more harmful than everyday plant-based foods such as grains, vegetable and fruits.” Irish PharmaChem | Industry Buyers Guide 2016

PACKAGING

Limerick Packaging: Leaders of the Pack Limerick Packaging have built up an enviable reputation for quality products and first class customer service, with a client base that includes some of the biggest names in the Irish pharmaceutical industry. When a host of packaging consumers were asked to rank in order of importance the attributes that make a very good packaging supplier, unsurprisingly, quality came out on top, followed closely by on-time delivery, with price coming just third. What separates good packaging suppliers from truly excellent companies is how well they know and understand their customers’ business. Very few packaging companies are capable of this, but it is an area where Limerick Packaging really excels. At the heart of Limerick Packaging’s ethos is their commitment to deliver “On Time, Everytime”. They do this by taking the time and effort to understand your business and usage patterns, and subsequently stocking products to order, in advance of your needs, and delivering weekly or daily as necessary. Limerick Packaging have an extensive client list across the pharma/medical and food industries in Ireland, and their customers can rest safe in the knowledge that the packaging materials they need are but a phone-call away. These companies no longer have stores full of boxes that they don’t need at that point in time and a packing hall without the boxes they do need. They have zero capital tied up in packaging stocks, allowing that money to be invested in turnover that perpetuates the business, with production and value-added activities where once they had stores.

Crowning the Customer Limerick Packaging has built up a reputation as the most reliable supplier of packaging

materials in all of Ireland and this is a position they are not going to relinquish any time soon. “Our philosophy is simple: we are dedicated to supplying quality products, “On time, everytime”, and at Limerick Packaging, the customer really is king,” notes Mike Boland, Sales Director and Co-Owner. Their extensive product range means that Limerick Packaging have something to suit most customers’ needs. “While 90% of our business is Corrugated Boxes in regular slotted case and die-cut formats, we now supply Litho printed outer boxes and inner cartons in very large quantities to a growing number of customers,” Mike notes. “We also supply industrial polythene bags, sheets and pallet hoods, pallet edgeguards, high quality postprinted boxes, pallet-wrap, strapping, strapping accessories, tapes and a full range of protective foams.”

Walking through their facility on the Ballysimon Road in Limerick, one is immediately struck by the cleanliness, tidiness, efficiency and sheer size of the factory, within which there is a barcoded storage system that not only controls stocks but also results in a ‘first in, first out’ stock rotation system. Established in June 2002, Limerick Packaging has grown to a formidable size and the staff are very proud to count some of the biggest names in the medical and pharmaceutical sectors among their many customers. Once they get to fully understand their customer’s

Irish PharmaChem | Industry Buyers Guide 2016

PACKAGING Impressive Product Range

Limerick Packaging’s range of products is quite impressive, and includes: • Corrugated Boxes (RSC, Die-Cut, Sheets, Pads, Divs. etc.); • Foam/Corrugated Composite Packs; • Eco-Friendly Thermal Packaging (Replacement for Moulded EPS); • Protective Foams (EPE,EPU, EPS, EPP); • Solid Board Leak-Proof Bases and Lids; • Litho Printed Cartons and Litho-Laminated Outers; • Bubble-Wrap, Rolls and Bubble

Bags; • Labels; • High Quality Post Printed Corrugated Boxes; • Pallet Wrap/Strapping/Strapping Accessories/Tapes; • Shelf-Ready/Retail-Ready Packs; • Industrial Polyethylene Bags, Sleeves and Sheets; • Pallet Edgeguards; • POS/POP Stands,Bins and Signage; • Packaging Assembly Machinery.

fleet, as this provides the flexibility necessary to meet all customer needs on a daily basis. “We are certified to ISO9001:2008 and we operate to ISO14001 and BRC/IOP,” Mike Boland notes.

Improving Performance

business, they stock product to Purchase Order and deliver daily or weekly as required. “For customers within our famous ‘stock and serve’ model, this means that they can call product off today before noon and we will deliver tomorrow, anywhere in Ireland,” Mike Boland states proudly.

Considerable Growth Limerick Packaging has experienced considerable growth in shelf ready/retail ready packs and also in Litho-laminated corrugated packs, due to the company’s ability to respond

Irish PharmaChem | Industry Buyers Guide 2016

and even pre-empt market trends, their ability to design effective solutions for their customers at very competitive prices and to assist their customers to get products innovatively packed to market in a timely fashion. Walking through their factory, you cannot help notice the purposeful approach each member of staff has in everything they do. Indeed, there is a steely determination to get everything right so that the company can succeed and prosper. Throughout the entire staff at Limerick Packaging, the one thing that stands out above all is the absolute focus on the customer’s needs, which is immediately evident in the ultra large screens throughout the factory, which track each order’s progress, outline the requirements for the next day’s deliveries and even break these down by county to optimise transport. The company also operates its own delivery

For a company with so many accolades and such a high profile client list, they could be forgiven for being content but Limerick Packaging are always looking to improve. “We are never happy,” laughs Mike, “and we are always striving to improve our performance and to create the ultimate customer experience. We are close but we are not there yet, and when we reach our goal, we will push on and once again set new standards for customer service.” Limerick Packaging has grown from humble beginnings in June 2002 to a very sizeable company today, and Connie Ryan, Managing Director and Co-Owner, attributes Limerick Packaging’s success to date “to the generosity of our many customers; in the first instance, for believing in us and placing their business with us; and for continuing to support us. Many of our customers who gave us business when we started have remained with us to this day. We have rewarded our customers with state of the art design and problem solving skills, trouble-free trading, competitive pricing and quality products delivered “on time, everytime”. We will continue to dedicate ourselves to our customers as we hope that many more fine customers will join in and be part of our success story.” For more information on Limerick Packaging, see www.limerickpackaging.ie.

Specialised Chemicals

Camida’s Chemistry with Customers Camida has been sourcing specialised chemicals for the life sciences, industrial and food sectors for 27 years, over which time it has developed into one of the most customer-focused and flexible companies in the industry.

From organic intermediates to biochemicals, performance chemicals to industrial and food ingredients, Camida can source, manage and deliver their customer’s requirements. Indeed, since its establishment in 1988, Camida has always been motivated and driven by the needs of its customers, and continues to be a highly responsive, flexible company who bring a comprehensive array of sourcing and supply options to customers.

Global Leaders With over 27 years’ experience in global supply and over 250 suppliers in more than 25 countries, Camida is uniquely equipped to meet high quality procurement needs

across a range of services, including: custom manufacture, packaging and distribution; process development; new compound development; and project management. For their clients, this invariably leads to improved performance and service. The team at Camida are proud of their long term relationship with global leaders in chemical manufacturing, including such well-known names as BASF, Lonza, Pennakem, Solvay, Contract Chemicals, Spectrum, Allnex, DuPont, Dorf Ketal, AgroHorizon, Kemtia and Handary.

Vendor Reduction Camida also have many years’ experience in vendor reduction programmes. These programmes include many additional customer benefits, are completely flexible and can be customised to meet the specific needs of customers.

Compliance & Quality Camida has been deeply involved in the pharmaceutical and life science industries since its inception and is fully compliant with all appropriate regulatory authorities. Camida is certified to I.S EN ISO 9001:2008 and holds SQAS/ESAD for Distributors. Camida is compliant with REACH Regulation (EC) No 1907/2006 for supply of chemicals.

Associations In addition to Camida’s long association with Pharmachemical Ireland (PCI) and the Chemical Business Association (CBA), this year saw Camida joining the Oil and Colour Chemist’s Association (OCCA) and the British Adhesives and Sealants Association (BASA), the trade association for the adhesives and sealants industry in the UK and Ireland.

“Camida is committed to meeting the highest industry standards and conforming to the most stringent international protocols,” notes a company spokesperson. “Tap into our global network and over 27 years’ experience in sourcing specialised chemicals. We understand your needs, we provide solutions, and above all, we exceed your expectations.” For more information, see www.camida.com or call + 353 (0) 52 6125455.

20Irish PharmaChem | Industry Buyers Guide 2016

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Regulatory Science Ireland

A coalition of the willing Regulatory Science Ireland is a network of interested parties, from academia to pharmaceutical companies, committed to the development of an integrated Irish response in the fields of research, education/ training and knowledge sharing, to the global regulatory science effort, writes Dr Anne Greene, Director, RSI The ever increasing complexity of health care products requires a data driven, evidence based approach to their regulation. This is understood and recognised worldwide and has driven the development of the discipline of regulatory science, which is described by the FDA and the EMA respectively as: ● “…the Science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA regulatory products” (Source: Advancing Regulatory Science at FDA, A strategic plan, August 2011);

● “…a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision making throughout the lifecycle of a medicine. It encompasses basic and applied medicinal science and social sciences and contributes to the development of regulatory standards and tools” (Source: European Medicines Agency’s contribution to science, medicines and health, Road Map to 2015, December 2010)

Regulatory Science Ireland (RSI) is new initiative, set up 18 months ago, as a national response to global initiatives in the emerging area

Minister for Health, Leo Varadkar TD and the first Chief Knowledge Officer of NASA, Ed Hoffman, pictured at Knowledge Management Dublin 2015.

of Regulatory Science, and has been described by the former CEO of the Health Products Regulatory Authority (HPRA), Pat O’Mahony as “the coalition of the willing” (Source: Pat O’Mahony, CEO, HPRA, Knowledge Management from Discovery to Patient, Dublin Castle, March 2015). RSI is a network of interested parties from academia, the pharmaceutical industry, the medical devices industry, the HPRA and Government agencies, all of whom are committed to the development of an integrated Irish response in the fields of research, education/ training and knowledge sharing, to the global regulatory science effort. It has been founded with the full support of the HPRA, and at the first symposium organised by RSI, Knowledge Management, Dublin 2015, the then CEO of HPRA, Pat O’Mahony, in the opening address, remarked: “Five years ago, this initiative would have been impossible in Ireland from our side…but now we’re saying as the regulator, we are involved front and centre in this initiative and we want to drive on this regulatory science agenda and RSI as the Irish contribution to the global initiative.” During the summer of 2015, RSI was formally constituted as a company, limited by guarantee (not for profit) with seven board members representing the individual constituent bodies of RSI. The Board of Directors meets on a monthly basis to develop RSI activities. The Board are also organising three regional information meetings at the end of 2015, in Cork, Galway and Dublin, to continue to spread the word about the role and function of the organisation. The first of these information meetings was held on September 8 in Cork and consisted of a half-day meeting event chaired by Anna Bradley ( RSI Chair), with a presentation about RSI by Professor Caitriona O’Driscoll from UCC School of Pharmacy (RSI Vice Chair). RSI’s mission is “to unite stakeholders, including Academia, Pharmaceutical and Medtech industries, the Regulator and Government agencies, in the pursuit of an integrated Irish response to global Regulatory Science initiatives that are beneficial to the patient”. RSI aims to achieve this mission through facilitation of relevant research, training and symposia, thereby creating an environment that: ● Facilitates Irish contributions to an effective response to the increasing complexity of healthcare products and their associated regulatory systems; ● Creates a cohort of Irish based Regulatory Science experts; ● Further strengthens the value proposition of Ireland as an attractive location for healthcare product related activities.

Regulatory Symposia In March 2015, RSI organised its first international symposium, entitled ‘Knowledge Management: From Discovery to Patient - Enabling knowledge flow, delivering safe and effective products’. This Knowledge Management Dublin 2015 (KM Dublin 2015) symposium was the first of its

Irish PharmaChem | Industry Buyers Guide 2016

Regulatory Science Ireland kind in this rapidly emerging area of integrating knowledge management and risk management in the development, manufacture, surveillance and regulation of pharmaceutical and medical device related health products. The event brought together thought leaders, health product regulators, life science industry practitioners and academics to explore the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. Amongst the high profile speakers at the event were Minister for Health, Leo Varadkar TD and the first Chief Knowledge Officer of NASA, Ed Hoffman, who shared with the packed audience lessons in Knowledge Management from the space industry.

Education and Training RSI has a number of expert committees, including a committee on education and training consisting of academic members from inside and outside of RSI. This body is in the process of gathering information about post-graduate training programmes being run in the various third level institutes across the country with possible interest to regulatory science. Once this inventory is prepared,

it will be publicised through the website, www.regulatoryscienceireland.com.

Research Projects The HPRA has been very supportive of research in RSI, and has co-funded two research projects, one on Biosimilars in conjunction with UCC and IPHA, and the other on Quality Defects in Medicinal Products in conjunction with DIT and PCI. The project on Biosimilars is intended to run over two years and has recently published its first article aimed at pharmacists in Hospital Pharmacy News, September 2015. The Quality Defect research is complete and the final report is currently being reviewed, with a view to publishing it early in 2016. This project is a pilot to a European-wide project co-ordinated by the European Medicines Agency looking at recurring quality defects in medicine. Finally, RSI is in the process of organising the recruitment of an Executive Director. It is hoped that the position will be filled early in 2016. This will be a fulltime position for a two-year duration. Apart from running the organisation, a key function of the successful candidate will be to further develop research funding capabilities for RSI and its research and educational projects.

RSI is organised with a Board of Directors, an Executive Director and Advisory Groups.

Pat O’Mahony, CEO, HPRA, addressing the Knowledge Management from Discovery to Patient symposium at Dublin Castle, March 2015.

Pictured are Anne Bradley, Astellas Ireland; Frank Hallinan, Adjunct Professor UCC School of Pharmacy; Mike Morris, HPRA; Professor Catriona O’Driscoll, UCC School of Pharmacy; and Kevin O’Donnell, HPRA, at the RSI seminar in the Raddison Blu Hotel, Little Ireland, Cork. Irish PharmaChem | Industry Buyers Guide 2016

Research & Development Pictured at the Pharma Industry Awards are (l-r): Dr Kristy Butler, Rosaleen Archbold, Aisling Arthur, Yvonne Diggins, Prof. Anne Marie Healy, Prof. Gavin Davey, Prof. Gavin Walker, Prof. Kieran Hodnett, Matt Moran, Director, PharmaChemical Ireland and Awards Judging Co-Ordinator, Dr Sarah Hayes and Dr Lijun Jia.

SSPC Wins Top Awards The Synthesis and Solid State Pharmaceutical Centre (SSPC), hosted at the University of Limerick, was one of the big winners at the Pharmaceutical Industry Awards, being named the Pharma Research Centre of the Year and Research and Development Achievement Award winner. “The SSPC is delighted to win these two prestigious awards, which recognise the cutting-edge research and development achievements of the SSPC’s world-leading researchers and globally leading industry partners,” said Professor Kieran Hodnett, SSPC Director. “SSPC’s research innovations and developments are leading the way for next generation medicines manufacture and it is truly a great honour to be acknowledged for these achievements by the Irish pharma sector.”

A Model for Collaboration The SSPC has featured regularly in the pages of the Irish PharmaChem Yearbook since its establishment in 2008 and for a very good reason. It is the largest collaborative scientific research organisation in the country and has become a model for collaboration between industry and academia, not just in Ireland but across the globe. A collaboration of 33 partners, made up of nine research performing institutions and 24 pharmaceutical and chemical companies, the SSPC research programme covers the pharmaceutical production chain, from molecule to medicine. It is jointly funded by the Irish Government, through Science Foundation Ireland and industry partners, with funding of €30 million and €10 million invested respectively. “Where we used to export challenges in the pharma sector, we’re now importing problems

The Synthesis and Solid State Pharmaceutical centre lifted the Pharma Research Centre of the Year and Research and Development Achievement Awards at the recent Pharma Industry Awards. and exporting solutions,” notes SSPC General Manager, Jon O’Halloran. “Our companies can import problems from their sister sites abroad, solve them in Ireland through knowledge gained in the SSPC and present that solution to the global HQ, demonstrating the value Irish sites bring to these global pharmaceutical companies, through their academic links here in Ireland. “Working with our industry partners and partner research institutions, we are helping to solve the most pressing questions for the pharmaceutical industry worldwide, helping them to increase efficiencies, reduce costs and widen the variety of drugs and treatments available in the market.”

Delivering Real Results Indeed, the SSPC is getting real results in terms of problem solving and innovation, and continues to attract some of the biggest names in scientific research worldwide. It

Pictured are SSPC General Manager, Jon O’Halloran, and SSPC Director, Prof. Kieran Hodnett.

now supports more than 130 researchers, including 38 principal research investigators, 34 post-doctorate researchers and 60 PhD students. Meanwhile, the SSPC’s industry partners include some of the biggest names in global pharmaceuticals, like Pfizer, Eli Lilly, Glaxo SmithKline, Janssen, Merck, Roche, Bristol Myers Squibb, Alkermes and Abbvie. The SSPC research programme is organised into three interconnecting strands, which actively reflect the three distinct steps in the manufacture of modern medicines. Strand 1: New Frontiers in Pharmaceutical Synthesis This focuses on better and more environmentally sustainable ways to make active pharmaceutical ingredients; Strand 2: Crystal Growth and Design Investigating optimal ways to produce active pharmaceutical ingredients; Strand 3: Drug Product Formulation and Manufacture Developing the dosage forms of the future. In addition, the SSPC has recently expanded its research remit into the biopharma and medical devices areas. The SSPC is hosted at the Materials and Surface Science Institute (MSSI), University of Limerick, and is partnered with University College Cork, University College Dublin, Trinity College Dublin, National University of Ireland Galway, Dublin City University, Athlone Institute of Technology, the National Institute for Bioprocessing Research and Training, and Waterford Institute of Technology. For more information, see www.sspc.ie. Irish PharmaChem | Industry Buyers Guide 2016

At Novartis, we live innovation At Novartis, we are driven by meeting patient needs. We lead the Pharma Industry in our global investment in R&D with currently over 140 clinical development projects in progress, and 25 clinical trials ongoing in Ireland alone. Our vision is to be Irelandâ&#x20AC;&#x2122;s most successful healthcare company: its premier innovator focused on improving patient outcomes, the most trusted company to our healthcare partners, and the best place to work for our associates. Our diverse portfolio in innovative prescription medicines, eye care products, affordable generic medicines, and consumer health therapies, is helping Irish people live better lives every day.

www.novartis.ie Date of Preparation: June 2015. IE02/LUC14-CNF162a

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Pharmaceutical Manufacturing and Technology Centre

PMTC: Facilitating Process Innovation

The PMTC is located in the Analog Devices building at the University of Limerick.

The Pharmaceutical Manufacturing and Technology Centre has proven itself to be a key player in the research landscape, working to achieve its vision of making Ireland a global hub of pharmaceutical process innovation.

Since its creation in 2013, the Pharmaceutical Manufacturing and Technology Centre (PMTC) has earned an enviable reputation for high quality research and development in the area of pharmaceutical process innovation. Utilising its flexible and highly collaborative engagement model to the fullest, PMTC constantly delivers proven benefits to its steadily growing base of industrial, academic and research members. Under the management of Centre Director, Dr Chris Edlin, PMTC now occupies a distinctive position in the Irish research landscape. Established jointly by IDA Ireland and Enterprise Ireland, PMTC is resourced with State funding of €5m over five years. With additional co-funding from industry partners, the Centre is focused on making Ireland the global hub of pharmaceutical process innovation and advanced manufacturing through applied research into advanced technology solutions. As a measure of its success in meeting the expectations of its funding sources, Dr Edlin is pleased to report that, in the relatively short time that PMTC has been in existence, the Centre has significantly leveraged the state investment. During the first 18 months of operations, the Centre has more than matched the State contribution to its research program through generation of new collaborative projects (state/non-exchequer/ industry funds) and in-kind contributions. Indeed, the Director is confident that these levels can be maintained and surpassed in the coming years.

The PMTC Research Team - a driver of success “The PMTC researchers are the greatest resources of the Technology Centre,” according to Dr Edlin. “Individually, the highly experienced team of Principal Investigators and researchers who work on the Centre’s research themes have brought

Members of the research group represent the Centre at national and international conferences and their publications regularly appear in highimpact journals.

Member Benefits

Dr Chris Edlin, Director, PTMC a wealth of knowledge from a wide range of fields. Areas of proficiency include those of mathematical modelling, powder processing and agglomeration, process optimisation, chemical engineering, polymer and electrochemistry and microbiology. As a group, their output has directly and positively impacted our industry partners and has been critical to providing tailored solutions to specific concerns.” PMTC also has Professor Gavin Walker on board as Academic Lead. Prof. Walker, appointed Bernal Chair of Pharmaceutical Powder Engineering at the University of Limerick in 2012, brings the benefit of his extensive industrial and research background to bear. A chartered engineer, whose primary focus is on industrially relevant research with MNCs and SMEs, he has led numerous industrially-funded research projects which have delivered innovations for some of the biggest companies in the world, including BP Chemicals, ExxonMobil, Bombardier Aerospace, AstraZeneca, GSK, Roche, Diageo, Almac and Seagate. He has published more than 130 international journal papers on materials engineering and is a member of the editorial board of six international chemical engineering journals.

Dr Edlin acknowledges that current and prospective members of the PTMC must be assured of a strong return on their investment of time, money and resources to the Centre. However, he describes the benefits offered to members as “concrete”, citing PMTC member’s unrivalled opportunity to inform 100% state funded multi-million euro research projects relevant to their specific company needs as one example. “They can take advantage of access to core research capability and skills in continuous processing, mathematical modelling, statistics and process optimisation,” he notes. “In addition, members can take advantage of professionally managed and timely access to IP and research outputs at fair market rates.” With insight gleaned from his previous roles in a number of pharmaceutical companies, Dr Edlin is aware that a difficulty in finding and retaining the right people for key roles is a common concern across the sector. Unfilled vacancies for crucial roles can hold back not only projected progress but the development of revenue generating projects and planned expansions. Dr Edlin outlines how engagement with PMTC offers companies valuable opportunities to identify talent for future recruitment. “The Centre has already been responsible for the training and transfer of multiple staff to our industry partners and we will continue to promote and support this process,” he reveals. Indeed, he feels that this opportunity to identify talent for future recruitment is one which may allow members of PMTC to pull ahead of their competitors. Irish PharmaChem | Industry Buyers Guide 2016

Pharmaceutical Manufacturing and Technology Centre As a testament to these benefits, PMTC continues to steadily increase its industrial and academic membership base, growing from 10 in 2014 to over 20 currently. Dr Edlin regularly undertakes site visits to develop the relationships with members and ensuring that he remains in touch with their particular needs.

Pictured at the PMTC knowledge day at the Kemmy Business School, University of Limerick, are Dr Chris Eldin, Director, PMTC, and Professor Gavin Walker, Bernal Chair of Pharmaceutical Powder Eng. Picture: Fusionshooters.

Events PMTC organises a comprehensive calendar of events and workshops spread across the year. “The objective behind these events is to get our current and potential members together to meet, network and learn,” the Director explains. Attendees can take advantage of the opportunity to engage with key players from industry, academia, regulatory and government agencies. Another expected outcome of these events is to identify opportunities to create and fund consortia to address contemporary research issues facing the sector. One such event was a very successful Maths workshop which focused on answering the question, ‘How can mathematical models be applied to optimise your manufacturing process?’ Stakeholders across the industry shared current best practice and new areas were identified, where core PMTC resources could be deployed to maximum collective benefit. Based on the problem statements developed, PMTC directors and facilitators compiled a corresponding description of needs document. This will ultimately lead to PMTC core funded research addressing the identified issues, Dr Edlin explains. Another example came from PTMC’s Knowledge Day, which was held on August 28 at the Kemmy Business School in the University of Limerick. Over 100 attendees gathered to hear presentations by PMTC researchers and industrialists on areas including powder modelling for tablet processing, 3D printing and advanced manufacturing technologies. “We were very pleased to host keynote speakers, including Martin Wallace (GSK), Stan O’Neill (The Compliance Group) and Charles Gordon (Britest). Dr John Lynch, the Director of Compliance at the Health Products Regulatory Authority, spoke on a topic which we felt was of particular significance to our audience - The Pharmaceutical Regulatory Framework and the role of HPRA and RSI,” Dr Edlin states. “While, each event is uniquely tailored to address a specific issue, they are all structured to provide valuable opportunities for networking between our industry, research and academic attendees,” he continues. “It is during these relatively informal settings that some of the best collaborations and ideas begin to take shape.”

Responding Directly to Industry Concerns The research undertaken by the Centre is always directed towards addressing industry concerns, its Director stresses. He highlights the recently launched Good Cleaning Validation document as a real-world example of PMTC responding directly Irish PharmaChem | Industry Buyers Guide 2016

to key areas of interest to its members. In order to address concerns relating to cleaning validation identified by attendees at their 2014 cleaning workshop, PMTC commissioned The Compliance Group to deliver a ‘good cleaning validation practice (GCVP)’ document. Based on a review of current guidelines and input from HPRA, the cleaning validation sub-team of PharmaChemical Ireland plus PMTC industry members, this is now available to download on www.pmtc.ie. A companion app, currently in preparation, will also be made available. However, the commitment to address the collective membership need does not end there; the Centre plans to scope research programs for methodologies and the use of Process Analysis Technologies and modelling in cleaning to further improve and refine this integral pharmaceutical process. PMTC has also developed a number of innovative and very promising technologies, including: a novel microbial apparatus for quantitative determination of bacterial contamination; a QbD approach for continuous processing in production processes; soft sensor modelling tools for critical processes, including freeze drying; and PAT methods for at line analysis and real time release. Dr Edlin points out that all of the projects resourced have significant commercial potential, due in the main to the fact they all evolved from a stakeholder driven needs analysis.

PMTC Research Themes PMTC makes comprehensive use of its strong core competences to deliver solutions across six main

PMTC is a finalist in the Irish Pharma Awards 2015 in the Partnership Alliance of the Year category.

industry-informed and sector focused themes: ● Advanced rapid micro-analytical techniques; ● Enabling and control of continuous processing; ● Soft sensor modelling tools; ● API real time release PAT; ● Powder processing; ● Cleaning, validation and verification.

Where To From Here? The PTMC Director admits that the environment in which the pharmaceutical industry operates can be one of flux and uncertainty. Companies, while contending with the effects of the patent cliff, must be able to adapt quickly to a host of issues, including increasingly stringent levels of regulation and sharp fluctuations in consumer demand for their products. However, Dr Edlin suggests that PMTC can be a valuable partner to companies as they address these and other challenges. “Members of our Technology Centre can take advantage of cutting edge research and development, tailored specifically to respond to specific sectoral concerns, such as cost competitiveness and issues surrounding APIs,” he explains. PMTC, a finalist in the Irish Pharma Awards 2015 in the Partnership Alliance of the Year category, continues to expand its membership base and to nurture the relationships formed to the mutual benefit of all parties involved. “The Centre has achieved a number of notable successes since its inception,” Dr Edlin notes, acknowledging that “these would not have been possible without the continued support we receive from the State through bodies such as IDA Ireland and Enterprise Ireland.” “Our proven ability to attract significant research and development funding from industrial, European and national funding agencies fuels our focus on delivering advanced technology solutions to address contemporary issues in pharmaceutical manufacturing,” concludes the Director, under whose direction PMTC looks set to continue distinguishing itself as a world class centre of excellence for the resolution of pharmaceutical manufacturing issues.

Biopharma

NIBRT â&#x20AC;&#x201C; Supporting Biopharma Growth The pilot plant at NIBRT includes 2 X 150L SS Bioreactors, as well as single use technologies.

Ireland has had great success in attracting major pharmaceutical companies to set up operations here, a success that goes back decades. These companies are here for the long haul; they have invested billions in building complex facilities to manufacture medicines and have provided highend jobs for tens of thousands of people working in and supporting this industry. The industry is currently undergoing dramatic change. It is now known generally as the biopharma industry, and most new medicines are of biological origin. All the big pharma companies, for example Pfizer, Roche and Sanofi, who have traditionally had their in-house R&D departments focused on small molecule discovery (synthetic chemical products) have changed their focus. The trend is to acquire Biotech companies; for example, Wyeth, Genentech, Genzyme, acquired by the above companies, who somewhat started this trend. Today, the acquisition of Biotech companies by big pharma is pervasive. The Allergan acquisition, for $66 billion, with a major facility in Westport, by Actavis is one of the more recent moves. And now the renamed company, Allergan, is being targeted by Pfizer. Indeed, the trend is towards not only the acquisition of established Biotech companies, but also the acquisition of small start-up companies who have potential products in development. For the big pharma companies, it is all about building a pipeline of new products, which are now predominantly biological in origin. To see how much this trend has already established

NIBRT is a world class institute, delivering training and research solutions to the global biopharma industry, writes its CEO, Dominic Carolan. Dominic Carolan, CEO.

itself, you need look no further than the list of top selling drugs in the world. Seven of the top 10 sellers in 2014 were biologics, with Humira, an Abbvie product for rheumatoid arthritis and other conditions, the top seller, with global sales of $13 billion. Another interesting trend is that all the major companies are also involved with Biosimilars. Many of the current blockbuster biologics will lose exclusivity this decade. The recent acquisition by Pfizer of Hospira for $17 billion, primarily to acquire their development pipeline of Biosimilars, is a case in point. Biosimilars will be the next wave of products: a number have been recently approved but have not yet impacted on the market.

Expansion in Ireland So how does this translate into what is happening in Ireland? We already have nine of the top 10 biopharma companies with manufacturing

operations in Ireland. Many of these also have a research and development component to their operations. A number of these companies are expanding or adding Bioprocessing facilities to their existing operations; for example, J&J, Lilly, Pfizer, BMS, Genzyme, Allergan, Mallinckrodt. The largest, still independent, Biotech companies are also here. Five of the top 10 (Gilead, Amgen, Regeneron, Alexion, and BioMarin) have or are establishing operations here. There have been recent very large new Bioprocessing announcements made, including those from BMS, Alexion and Regeneron, to name a few of the larger projects which will result in excess of $1.8 billion in new facilities, hundreds of new permanent highly skilled jobs and thousands of construction jobs. These facilities are technically complex, expensive to build and to operate. From start of construction to having Irish PharmaChem | Industry Buyers Guide 2016

Biopharma supply of commercial product can take three or four years. Because of the expense of these facilities, this business is here for the long haul, as has already been demonstrated by the strength of the more traditional pharma industry here.

The NIBRT facility features a 6,500 m2 stateof-the-art pilot scale manufacturing plant with associated laboratories and currently in excess of 50 employees.

NIBRT NIBRT is a world class institute, delivering training and research solutions to the global biopharma industry. Established by IDA Ireland (€57 million funding), NIBRT partners with all Higher Educational Institutes in Ireland involved in bioprocessing. We work with industry to support international best practice in biologics operations. NIBRT provides a unique training and research facility – the biopharma equivalent of a flight simulator.

So what does NIBRT do? NIBRT’s mission is to support the development of the biopharma industry by providing world class research and training solutions. We are committed to: ● Train and educate undergraduates, graduates and industry employees in the understanding of bioprocessing and the techniques utilised by the industry in manufacturing complex biological medicines. Over 3,300 trainees spent 14,000 training days in the NIBRT facility in 2014, with a significant uplift on these numbers in 2015 due to the growth in the industry. 23% of these trainees were international. ● Collaborate

with industry on scientific research to drive biopharma innovation. Research collaborations on innovative technologies and techniques continue to grow in 2015. Some of the interesting projects here include extractable and leachables in single use technologies, mobile sensors for PAT, to name just two. Industry collaborations are in excess of 10, with a multiple of this with other research institutes and colleges. NIBRT has a global reputation for Glycan analysis and Product Characterisation.

● Support major biopharma investment in Ireland. All the major start-ups have been supported by training of core personnel in the NIBRT facility. In 2015, significant start-ups that were supported included: Regeneron, Lilly, BioMarin, Genzyme. Plans are progressing regarding support of the BMS and Alexion major start-ups. ● Provide a test bed for new technologies and processes. Many of the new products for Bioanalytics and bioprocessing are tested and showcased in NIBRT.

Dedicated Biopharma Research “NIBRT is the only dedicated biopharma research and training institute in the world. The institute plays a key part in positioning Ireland as a location of choice for international biopharma development projects,” noted Martin Shanahan, CEO, IDA Ireland, in April 2015. But it’s not just those in government departments or agencies like the IDA who see the value of what we do, as exemplified by the following testimonial from a Springboard student in December 2014:

“NIBRT had a huge impact on my employability for this sector. My learning with NIBRT has really allowed me to hit the ground running, as the course was so specific to the job I actually perform. It is hands down the best decision I have made so far in terms of career progression. I would 100% recommend this course, it’s a no brainer.” For more information, visit www.nibrt.ie.

NIBRT’s mission is to support the development of the biopharma industry by providing world class research and training solutions.

Trainees in the NIBRT pilot plant.

Irish PharmaChem | Industry Buyers Guide 2016

Counterfeit Medicines be proactive in identifying emerging threats and dealing with them to lessen their impact or even eliminate them before they become major issues. Identification, detection, disruption and dismantling of illegal activity at an early stage will minimise the threat to public health. Prevention, where it works, is a better use of scarce resources and a better guarantee for the protection of public health. Preventative action is often not highlighted in the public domain but is a key success factor for protecting the marketplace. Of course, we have to recognise that we will not always be successful in prevention. Fortunately, to date, the HPRA have not identified any falsified medicines in the legitimate supply chain in Ireland. They continue to monitor and routinely analyse product taken from the market.

Illegal Routes of Supply

Countering the Counterfeiters The HPRA is committed to interagency cooperation, both nationally and internationally, as it works to protect public health from the threat posed by falsified medicine products. Public health authorities throughout the world face growing challenges from the threat of falsified/counterfeit health products and the ever increasing involvement of criminals in these activities. Here in Ireland, the role of the Health Products Regulatory Authority (HPRA) is to protect and enhance public and animal health through the regulation of medicines, medical devices and other health products that are manufactured or marketed in Ireland. The HPRA acts to detect and prevent any threat involving counterfeit health products that come within its remit. The recent Interpol coordinated operation Pangea VIII (Operation Pangea VIII, 2015: www. interpol.int/Crime-areas/Pharmaceuticalcrime/Operations/Operation-Pangea), which focused on the illegal trade in the online supply of medicines and medical devices, resulted in seizures and detentions worldwide of $80 million in value, mostly in falsified and illegally supplied medicines. This highlights the ongoing threat to public health and to the legitimate industry.

Protecting the Legitimate Supply Chain Criminals know that infiltrating the legitimate

supply chain is how they can make most money. As the regulator, the HPRA’s job is to implement preventative measures aimed at maintaining a secure supply chain. They approach this by regulatory engagement with the trade and industry and by providing advice and support through the various regulatory activities, such as inspections, market surveillance and information days. Successful engagement is essential for maintaining compliance with GMP and GDP, and conformance with the essential requirements (for medical devices). This aids the prevention of any diversion into or out of the supply chain or the involvement of unauthorised actors, such as unregistered brokers and unauthorised manufacturers or wholesalers. It is now well recognised that wholesalers are the gatekeepers that prevent the leakage of medicines into or out of the legitimate supply chain. The potential for criminality in the legitimate supply chain has been weakened with the strengthening of controls brought in by the EU Falsified Medicines Directive. However, this potential still exists. The normal regulatory activities alone will not resolve the challenges. Combining these activities with those of its inhouse enforcement unit enables the HPRA to

Pharmaceutical and other health productrelated crimes are an international trade, with organised crime elements involved at all levels, including operating whole networks on the internet to supply falsified medicines and medical devices. While global in its operation, pharmaceutical and health product related crime is local in its impact. The HPRA engages with and cooperates with other regulatory, law enforcement and customs organisations, locally and globally. It is through these combined and concerted efforts that we can make a real difference: if the authorities do not co-operate, the criminals will succeed, public health will suffer and the reputation of industry and legitimate products may be damaged. It is clear that there is constant criminal intent to divert legitimate medicines and medical devices into the illicit market. This is often referred to as the grey or black market and is growing. The relative ease of procurement through unregulated online suppliers, popularly but erroneously referred to as ‘internet pharmacies’, presents an ever increasing challenge.

National Response to Illegal Supplies The HPRA works closely with Revenue’s Customs Service to prevent these risky falsified/ counterfeit health products, ordered online, from getting to their destinations. This has proven to be beneficial. The HPRA also works closely with An Garda Síochána and Revenue’s Customs Service in relation to investigative operations. Together, they take a cooperative interagency approach to such illegal activities and often conduct joint operations. While this is evident in their joint investigative approach throughout the year, it is most obvious around Operation Pangea, the Interpol coordinated operation to counter illegal online supplies. Each year, the HPRA, An Garda Síochána and the Revenue’s Customs Service come together in a single organising committee to plan and operate joint operations where they Irish PharmaChem | Industry Buyers Guide 2016

Specialist Pharmaceutical Storage Solutions At CRS Pharma Solutions we have been designing, manufacturing and supplying specialist temperature controlled storage solutions to the Pharmaceutical industry for over 20 years. Throughout this time we have built up a highly skilled and knowledgeable team within CRS Pharma Solutions, all of who are trained in, experienced in and work to the strictest guidelines. Our variety of temperature control solutions range from low temperature freezing to high capacity storage including:

2-8 Degree Chilled Storage

Hot Box Storage

Close Control Freezer Storage

Blast/Shock Chillers & Freezers

Incubator Storage

Ultra Low Temperature Freezing

Atex Storage

Customised Solutions

All of our equipment is designed specifically for storage of high value pharmaceutical product and has passed our internal temperature mapping studies prior to installation. This equipment is specifically used in the pharmaceutical industry throughout its life. Features include: •

Design and Manufacture to highest standards

•

GxP Compliant Pharmaceutical Portable Storage Solutions

•

Over 20 years experience

•

Compliant with all ISO 9001 Quality Management Systems

•

Product temperature range from -70°C to +60°C

•

Products in our Pharmagrade range are fully CE marked

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Full IQ, OQ, PQ validation, including empty and full load thermal mapping studies

•

Turnkey Customised Solutions

•

Compliant with all Health & Safety at Work Regulations

To discuss any future project call us now on 1890 929 824 or alternately email Patrick Tyrrell at patrick.tyrrell@crspharmasolutions.ie

www.crspharmasolutions.ie

Irish PharmaChem | Industry Buyers Guide 2016

45 Call our CRS Technical Team on 1890 929 824

Counterfeit Medicines maximise their resources and powers to identify and investigate criminal activity relating to illicit online sales of medicines. The HPRA recognises that its efforts alone cannot adequately address this issue, which is truly global in nature. No one agency, whether a health products regulator, police or customs, has the resources to do all that needs to be done. For this reason, all three authorities must work together and work with other agencies abroad towards the common goal of protecting public health. Raising awareness amongst the public of the health risks posed by falsified products and illegal routes of supply is also a key part of the HPRA’s strategy. The HPRA continues to stress to consumers the potential health risk association with purchasing prescription medicines online. For further information, consumers are urged to access the HPRA leaflet ‘The Dangers of Buying Prescription Medicines Online’, which is available on its website at www.hpra.ie.

International Response to Illegal Supplies In addition to the national approach, the HPRA actively engages internationally with law enforcement agencies, including participation in the Interpol Planning Committee for Operation Pangea. In order to support investigative activities, HPRA takes the approach of fostering, on a wide front, the development of standards in the investigation of crime involving health products. They are active regionally in Europe with the EU’s Heads of Medicines Agencies Working Group of Enforcement Officers and the Council of Europe’s Counterfeit Medicines Committee. On a global basis, they are active members of the Permanent Forum on International Pharmaceutical Crime (PFIPC), and of WHO’s Member State Mechanism on substandard/spurious/falsified/falsely labelled/ counterfeit (SSFFC) medical products. The HPRA have been active in the development of legal standards to support enforcement actions. This involved supporting

the development of the Council of Europe’s Medicrime Convention and the UN Office on Drugs and Crime (UNODC) Guide to drafting of Model Legislation on fraudulent medical products.

Increase in Enforcement Case-Load Notwithstanding all these efforts, we still see resilience in the illicit supply of medicines and medical devices. There has been a noticeable increase in the HPRA’s enforcement caseload over the past 10 years, with a 10-fold increase during this time. The profile of their investigative work also changes in line with the changes in the illicit market. Sedative products, such as those containing Zopiclone or Diazepam, are now illegally sold by criminals for abuse purposes. In 2014, these accounted for 56% of the HPRA’s product detentions (by number of dosage units) in investigations. This was up from 19% in 2012 and 51% in 2013. A lot of effort by the HPRA and their partner investigative agencies has been put into

addressing this risk over the last three years. This is a major challenge and will continue with a view to curtailing the sources for such supplies. The HPRA also place a lot of emphasis on reducing the threats posed by slimming products, particularly those containing the active substance Sibutramine. There has been a steady decrease in the percentage share of detentions over the last three years, with 20% in 2012, 19% in 2013 and down to 11% this year to date. Other prescription medicines have been found on the illegal market, but not in large quantities. However, product displacement in the illegal market means that, when activity in one area decreases, it usually increases in another. The illicit market in erectile dysfunction products has steadily fluctuated over the last three years from 6% in 2012 to 11% in 2014. This means that the HPRA have to be vigilant not just to the changes in the market, but also to the impact that their enforcement work may have by making certain abuse areas less attractive to criminals at particular times. They apply a risk-based approach to enforcement work and focus on those issues of greatest threat to health. This means, again, focusing on creating strategic alliances, both nationally and internationally. The impact to trade from the illegal and diverted supply sector should be limited as there is little displacement from the legitimate market. This is due to the inability of consumers to access such medicines in the legitimate supply chain. The HPRA will continue with its vigilance to prevent legitimate health products leaking out of or falsified health product infiltrating into the legitimate supply chain. It will also continue to engage in interagency cooperation, both nationally and internationally, to prevent the supply of falsified health products. Its approach is intelligence led and the HPRA actively welcome any information that will help in their efforts to protect consumers.

Sedative products, such as those containing Zopiclone or Diazepam, are now illegally sold by criminals for abuse purposes. In 2014, these accounted for 56% of the HPRA’s product detentions (by number of dosage units) in investigations.

Irish PharmaChem | Industry Buyers Guide 2016

Inspections Implementing a robust GxP inspection readiness programme is essential, writes Ann McGee, MD of McGee Pharma International.

Before an inspector calls...

A robust inspection readiness programme is essential to ensuring that your GxP operations are adequately prepared for regulatory inspection by a Competent Authority. The objective of a Pre-Approval Inspection (PAI) is to determine Good Manufacturing Practice (GMP) compliance to support regulatory approval of a regulatory filing for a product licence: for example, a PAI for a New Drug Application (NDA). For routine inspections, the purpose is to confirm ongoing GMP compliance at a manufacturing facility. A well-established and integrated inspection readiness program will: ● Ensure an organisation’s operations address the current regulatory inspection “hot topics”; ● Ensure operations are robust and compliant with GMP requirements; ● Confirm the structure, design and implementation of an organisation’s Quality Management System (QMS) are robust; ● Identify and address quality and compliance remediation activities in advance of regulatory inspection.

requirements and best practice standards. This can take the form of a gap analysis or audit.

Key Activities

● Regulatory inspection strategy and

Key to the success of an inspection readiness programme is that it is structured and meets the specific needs and requirements of an organisation. The following is an outline of activities that warrant consideration to be conducted as part of a site inspection readiness programme:

Gap Analysis / Audit: This initial element evaluates the current level of regulatory compliance against regulatory

Mock Regulatory Inspection: A mock regulatory inspection ensures that remediation activities are identified and a remediation programme is in place prior to regulatory inspection.

Gap Remediation: A gap remediation plan should be developed, with specific actions identified to address compliance gaps. A risk-based approach should be applied to the prioritisation of gap remediation activities.

Inspection Preparation: Once an inspection plan or record is available for the year, or a date is finalised for an organisation’s next regulatory inspection (either PAI or routine), tailored inspection preparation activities should be implemented. Considerations should include the following elements: preparation programme development; ● Identification of an organisation’s

inspection team, including assignment of roles during the course of regulatory inspection, e.g., host, escort and scribe; ● Advance mentoring and coaching of an

organisation’s SMEs, following the mock inspection, and advice on inspection ‘do’s and don’ts’; ● Co-ordination of a remediation

programme log to monitor improvements

and action plans with assigned owners against agreed implementation timelines.

Inspection Conduct: An inspection support team should be assembled to ensure that the inspection is structured and that all Auditor requests are handled in a timely manner. A daily inspection support team meeting should be conducted to ensure any immediate improvement actions to are addressed during the course of inspection.

Inspection Follow-up: Following regulatory inspection, senior management should act in a sponsorship capacity to ensure that the remediation plans and programmes are aligned with required remediation activities. It is also essential to ensure that inspection responses are submitted to the regulatory agency within the required timeframes.

McGee Pharma International McGee Pharma International (MPI) provides an inspection readiness service which facilitates Quality improvements through the identification of opportunities for systems, process and procedure improvements. Whether it is the US FDA, an EU or another Competent Authority inspecting you, MPI can assist to ensure that your organisation’s operations are ‘Inspection Ready’ at all times. MPI can support your organisation’s full inspection readiness programme or provide specific elements of support as outlined above as part of a wider internal inspection readiness programme.”

Irish PharmaChem | Industry Buyers Guide 2016

Material Handling

Toyota’s New High Performance Stacker Trucks Toyota Material Handling has released a complete new range of platform stackers on the European market. The new BT Staxio P-series includes 11 models from 1.2 up to 2.0 tonnes and shares many characteristics with the award-winning BT Levio P-Series powered pallet truck that was successfully launched last year. Designed for horizontal transport and stacking in intensive applications, the adaptable BT Staxio SPE range offers the right model for each application: the SPE120/140/160/200 with fixed support arm models for open pallet handling; the models SPE120L/140L/160L/200L with elevating support arm for use on uneven floors or double load handling; the straddle support arm model SPE140S to work with different pallet sizes; and the dedicated double stackers (SPE200DN/200D) with a special narrow version for intensive loading and unloading applications. With a vast amount of versatility, this range allows you to truly access all areas. Compact, reliable and designed for intensive work, the new BT Staxio P-series reaches 6m lift heights, the highest in its class, and 10km drive speed for quick material handling. Residual

capacities are increased compared to the previous model and are class-leading. This is achieved by the advanced truck technology that delivers superb stability when lifting. The SPE is built around the operator, with low noise and vibration, 180° powered steering with ergonomic handle and an adjustable steering arm height, which ensures that working with this range is a pleasure. Safety is enhanced with the ‘Totalview’ concept, allowing excellent visibility through the mast to the fork tips at any height. Driver protection solutions, consisting of foldable gates, fixed sideguards or backrest and speed control when cornering, all support the smooth and safe handling of goods. At the same time, Toyota Material Handling also extends its BT Staxio W-series with seven

new models. The new heavy-duty pedestrian SWE range includes 1.40, 1.45, 1.6 and 2.0t models, offering the same strengths in terms of productivity, reliability, safety and ergonomics as the new platform version. Both new ranges are also available as cold store versions. “Our new BT Staxio SPE and SWE trucks are ideal for high intensity applications and are true multitaskers. They are designed to perform in a safe, productive but also energy efficient way. These trucks also exist in a Lithium-Ion version to optimise energy and cost-efficiency even further,” says Martin Mimer, Product Management Warehouse Trucks at Toyota Material Handling Europe. “The new BT Staxio trucks also come with Toyota I_Site as an option, improving safety and productivity for our customers.” Irish PharmaChem | Industry Buyers Guide 2016

THe new TRaIgo 80. MoRe pRoDucTIve, safeR anD MoRe eneRgy effIcIenT THan eveR. It moves faster through the aisles, handling both heavy loads and tight corners with perfect balance. It combines agile performance and leading edge technology with sheer robustness and stability. And it does all this with 20% higher energy efficiency than its predecessor, making it the most energy efficient truck on the market. Toyota is indeed progress on wheels. www.toyota-forklifts.ie

www.toyota-forklifts.ie or Toyota Material Handling Ireland at Toyota Ireland, Killeen Road, Dublin 12. Tel: 01 4190200.

Irish PharmaChem | Industry Buyers Guide 2016

4848_TY_Traigo80_Ad_A4_Portrait.indd 1

45 25/04/2013 12:43

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Irish PharmaChem | Industry Buyers Guide 2016

Traceability

Are You Ready for FMD? Did you know that between June 9-16, 2015, in just one week, a record 20.7 million fake and illicit medicines, with an estimated value of $81 million were seized, including blood pressure medication, erectile dysfunction pills, cancer medication and nutritional supplements. This was part of Operation Pangea, an international week of action tackling the online sale of counterfeit and illicit medicines and highlighting the dangers of buying medicines online. Coordinated by Interpol, the annual operation brings together customs, health regulators, national police and the private sector from countries around the world. Healthcare systems around the globe are facing challenges that affect the entire supply chain. The sector is concerned primarily with two main issues: patient safety and greater supply chain efficiency and accuracy. The facility to identify things uniquely and accurately is essential, be it a medication, an item of clinical equipment or even a patient. The regulatory landscape continues to evolve globally. New regulations in the EU, the US and elsewhere will have a major direct impact on the healthcare supply chain.

Ensuring Regulatory Compliance Product serialisation, compliance with EU, FDA and other international drug pedigree requirements and establishing anticounterfeiting solutions are key priorities for the pharmaceutical industry. The EU Falsified Medicines Directive (FMD) which seeks to establish a more secure supply chain for the distribution of prescribed medicines, will require the serialisation of patient packs, as Irish PharmaChem | Industry Buyers Guide 2016

When it comes to traceability of medicines and the Falsified Medicines Directive (FMD), your organisation needs to start preparing now, writes Siobhain Duggan, Director of Innovation and Healthcare, GS1 Ireland. The introduction of the European Falsified Medicines Directive means all manufacturers of prescription medicines will be expected to print a 2D datamatrix barcode with serialisation data on medicine packs and these packs then need to be verified at the point of dispensing.

well as tamper evident labelling to enable the authentication of medicines prior to being dispensed to patients. The European Federation of Pharmaceutical Industry Associations (EFPIA) has developed and successfully piloted an authentication solution based on GS1 automatic identification and data capture standards, together with the use of a standards-based federated database, which ensures that a retail pharmacy can check the authenticity of a medicine before dispensing to a patient. In January 2012, GS1 and EFPIA issued a joint vision statement for achieving the EU regulatory requirements. The introduction of the European Falsified Medicines Directive means all manufacturers of prescription medicines will be expected to print a 2D datamatrix barcode with serialisation data on medicine packs and these packs then need to be verified at the point of dispensing. This requires significant changes for pharmaceutical manufacturers and will require IT development changes in hospitals and community pharmacies. The draft Delegated Acts for the European Falsified Medicines Directive were published earlier this year and the Final Acts are expected by the end of 2015. The new legislation is expected to take effect three years after publication of the delegated acts for countries without pre-existing measures, and six years for countries with pre-existing measures. In the Irish context, this means that all prescription

Traceability

medicines sold in Ireland will need to be fully EU-FMD compliant by the end of 2018.

A Framework for Validating Pharmaceuticals The EU medicine authentication system will consist of: ● A Unique identifier (UI) – a 2D barcode (ISO compliant) containing four mandatory elements: product code, serialisation number, batch number and expiry date, the national reimbursement number can be included (optional), if requested by the Member State; ● Verification of the safety features: systematic verification of the safety features at the dispensing point, supplemented by riskbased verification by wholesale distributors. Note the choice of the most appropriate anti-tampering device will be left to the manufacturer; ● Establishment, management and accessibility of the repository system for the Unique Identifier (UI) by stakeholders. A repository has been established by the European Stakeholder Model (ESM) and is managed by the European Medicines Verification Organisation (EMVO). Manufacturers will upload information relating to the medicines packs being shipped to Europe. Each member country is expected to establish an NMVO (National Medicines Verification Organisation)

About GS1

GS1 is an international, neutral, not-for-profit organisation with operations in 112 countries around the world, including Ireland. The GS1 system of standards is the most widely-used system of supply chain standards, serving more than two million organisations (both public and private sector) worldwide. In addition to the traditional sectors of grocery, foodservice and DIY, membership in Ireland also includes the Health Service Executive (HSE), with over 40 hospitals and many suppliers of healthcare products. GS1 is recognised by organisations such as the International Organisation for Standardisation (ISO), and the European Committee for Standardisation (CEN). For more information, contact: Siobhain Duggan, Director of Innovation and Healthcare. Email: siobhain.duggan@gs1ie.org Twitter: @sioduggan_GS1 Web: www.gs1ie.org/Healthcare Tel: (01) 2080660

to oversee the implementation of the national repository, which should be interoperable and interconnected with the other repositories.

There is Less Time Than You Think – Act Now Implementation of the Falsified Medicines Directive requires many different disciplines. Developing solutions will be a team effort, with manufacturers assembling consortia of specialists in coding, imaging, data management and handling. Be warned: this will take time and manufacturers are finding there is less time than they think. Based on experience, it can take six months to select vendor partners, anything up to a year to set up and test the pilot packaging line, and a further year to then upgrade other lines, each of which will differ slightly from the pilot. So team selection needs to start now! In addition to the FMD legislation, the proposed European and existing US FDA Unique Device Identification (UDI) regulations are to the fore in the medical device arena and companies need to transform disparate medical identification methods into a standardised UDI system. Both pharmaceutical and medical device manufacturers are leveraging GS1 standards and the support of GS1 experts, to prepare for these new requirements and ensure regulatory compliance. Get involved! Go to www.GS1ie. org/Healthcare.

Why GS1 Standards? Use of GS1 standards enables traceability and promotes a safe and secure supply chain by providing greater visibility, accuracy and efficiency for the benefit of all parties. Preventing medical errors, enabling traceability and recall and combating counterfeiting are key concerns facing the sector, and GS1 standards are helping to solve these issues.

The Benefits of Adopting GS1 Standards in Healthcare • • • • • • • • • • •

Improving patient safety Lowering costs through increased efficiency Reducing medication errors Enabling supply chain visibility Facilitating effective product recalls Tracking pharmaceutical products/medical devices Reducing introduction of counterfeit products Enhancing inventory management Linking critical product data to the patient record Supporting regulatory compliance Optimising order, invoice, sales reporting, and chargeback/rebate processes

References: 1. The EU FMD Whitepaper – Domino Printing (Sep 2012) 2. http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea 3. GS1 Healthcare and EFPIA shared vision for product identification in the context of the EU FMD: http://www. efpia.eu/uploads/Modules/Documents/efpia-gs1shared-vision-090312_2.pdf

The EU Falsified Medicines Directive seeks to establish a more secure supply chain for the distribution of prescribed medicines. Irish PharmaChem | Industry Buyers Guide 2016

Recruitment

The Scientific Approach to Recruitment consultants working with us who understand the industry. With over 15 years of experience in recruiting directly for the life sciences industry, we have established a recruitment service that is committed to delivery. Thornshaw Scientific work with many of the top 20 global pharmaceutical, clinical research and medical device organisations. “By engaging with our consultants, job seekers gain instant access to a network of leading global employers who rely on us to keep them informed of the best new talent as soon as it becomes available,” Dunne says.

Thornshaw Scientific was established in 1999 and is a leading provider of staffing, recruitment, training and outsourcing services to the pharmaceutical, medical devices, clinical research, biotechnology and related healthcare industries. They recruit across all levels and across all functions within the science area, operating nationwide, as well as in the UK and mainland Europe. Thornshaw Scientific’s success record is based on understanding both candidate and client needs. “Our strength is our people,” explains Tina Dunne, Manager. “We have highly trained

As members of the National Recruitment Federation, Thornshaw Scientific operate to specific codes of conduct. “Our selection processes exceed industry best practice and our promise is to deliver a premium quality service to our clients at all

times,” Dunne stresses. Thornshaw Scientific has a track record of exceptional service delivery in permanent, temporary and contract placements. For more information, visit www.thornshaw.com

Scientific Recruitment As a company we’re only as good as the people we work with, which is why we only work with the best – the best clients, the best candidates, the best employees.

For more information on our recruitment services contact us on: Telephone: +353 1 2784671 Email: info@thornshawscientific.com

WWW.THORNSHAW.COM Irish PharmaChem | Industry Buyers Guide 2016

Supply Chain

Your Premier Supply Chain Partner As a premier global supply chain solutions partner to the pharmaceutical industry, the experts at Univar Pharmaceutical Ingredients understand the importance of having access to a safe and dependable supply of quality and performance-based ingredients for your pharmaceutical formulations. With long-standing, strong relationships with premier producers of technologies and ingredients, Univar’s extensive global network provides pharmaceutical manufacturers with one-stop access to a broad range of specialty active pharmaceutical ingredients (APIs), excipients, and process ingredients, when and where customers need them. On top of that, Univar offers broad technical and regulatory expertise that enables the safe delivery of a total solutions approach, from product

selection and regulatory compliance to scaleup and commercialisation. Univar Pharma Ingredients safely delivers value to customers in four key areas: ● Customer

Service: focused teams understanding customer needs, handling ingredient demand, managing supply chains, and delivering satisfaction; ● Quality Assurance: ensuring their customers receive the right types of materials, with the correct audit trail and full traceability, along with change control processes; ● Security of Supply: global supply chains with strong partners who are here today and tomorrow; ● Technical Support: ensuring all documentation is completed on time and

in full, to meet the needs of the relevant authorities and providing product guidance as required. Univar’s team of dedicated pharmaceutical specialists are intimately familiar with the pressures facing today’s pharmaceutical manufacturers, from global economic effects on healthcare budgets and increased regulatory demand to competing in an increasingly competitive global market. Univar’s experts work closely with customers to address individual challenges by developing tailored solutions to help reduce total costs of operation, while providing a dependable and secure source of supply. For more information, email irelandsalesoffice@univar.com.

Access delivered We understand the importance of having access to a safe and dependable supply of quality and performance-based ingredients for your pharmaceutical formulations. That’s why we operate one of the most extensive and secure supply chain networks in the world. With long-standing, strong relationships with premier manufacturers, Univar’s global reach provides you with one-stop access to a broad range of specialty API, excipients, and process ingredients, when and where you need them. On top of that, our broad technical and regulatory expertise enables us to deliver a total solutions approach – from product selection and regulatory compliance to scale-up and commercialisation. For more information on Univar Pharmaceutical Ingredients, visit www.univar.com/emea or contact us at Irelandsalesoffice@unviar.com or call us on +353 1 4019817. © 2015. Univar BV. All rights reserved. 00008183-2015

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Irish PharmaChem | Industry Buyers Guide 2016

CONTRACT MANUFACTURING B. Braun supplies healthcare markets worldwide, employing 54,000 people. Indeed, the company is currently represented in more than 62 countries across the world and the portfolio comprises more than 120,000 pharmaceutical and medical articles. Based on the synergy of this concentrated expertise, the B. Braun OEM Division offers a broad range of standard products and contract manufacturing services for medical devices and pharmaceutical solutions for the healthcare industry. These include: ● Contract manufacturing of parenterals; ● Medical devices for the application of parenteral drugs; ● Product development, combination and market-specific adaptions; ● Regulatory support and technical documentation; ● Competent local sales managers and international project managers.

The B2B division of B. Braun B. Braun OEM offers standard products or customised versions. Even the standard range contains hundreds of product versions, with which countless applications can be implemented. Their standard product range includes: ● Infusion and injection solutions;

B. Braun OEM: Your Partner for Success B. Braun OEM Division’s expertise in contract manufacturing and infusion therapy products makes them the right partner for tailor-made solutions in the healthcare industry. ● Medical devices for drug admixture; ● Automated infusion pumps; ● Products for venipuncture and injection; ● Products for infection prevention.

OEM specialises in developing customerspecific solutions for customers, and most of their products can be individually adapted to your requirements. Their range of customised products and services includes: ● Contract manufacturing; ● Product development and private labeling;

B. Braun has been designing, engineering and manufacturing medical devices for more than 175 years

B. Braun OEM Division offers a broad range of standard products and contract manufacturing services for medical devices and pharmaceutical solutions for the healthcare industry. Irish PharmaChem | Industry Buyers Guide 2016

● Product combination.

Contract Manufacturing If you are searching for a reliable partner for contract manufacturing of your drugs, B. Braun OEM is the perfect solution. Based on their extensive experience, they manufacture and fill pharmaceuticals according to your needs. B. Braun offer contract manufacturing for infusion, irrigation and volume replacement solutions, as well as standard injectables, anaesthetics and dermatological products. Depending on the product requirements, they can fill containers of different sizes, shapes and materials. If you cannot find a suitable product in their 120,000 articles range, B. Braun OEM are happy to provide customers with your individual solutions – from product variation to complete new developments.

Product Combination You have invested years of development work and all your expertise into your drugs. Therefore, it is all the more important that your drugs are administered exactly as you have intended. To be on the safe side, customers can simply use B. Braun’s medical products to configure an individual application kit that corresponds exactly to their needs. B. Braun has been designing, engineering and manufacturing medical devices for more than 175 years and has the experience and expertise that help to produce customised products with the same unmatched quality as standard products. Customers all over the world take the advantage of this ability to build and assemble medical devices with efficiency and accuracy. Their sales and project management teams have the expertise to turn your ideas into reality. For more information please, contact: B. Braun Medical Ireland Ltd, OEM Division Europe, 3 Naas Road Industrial Park, Naas Road, Dublin 12. Tel: (01) 7091834. E-Mail: robert.bannon@bbraun.com. or call Robert on 086 8339836 Web: www.bbraunoem.com. www.kitpacking-bbraun.com.

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Irish PharmaChem | Industry Buyers Guide 2016

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Stability Storage

An Opportunity for Cost Efficiency Q1 Scientific offers outsourcing of stability storage to pharmaceutical and life science companies. Stability storage is an essential regulatory requirement for both R&D and finished products and this is a function identified by Waterford business, Q1Scientific, as an outsourcing service they can provide to pharmaceutical and life science companies. Clients can benefit from lower costs but also increased efficiencies. Q1 Scientific not only provides customers with cost efficient services but also creates long-term value through their collaborative partnerships. Contracting stability sample storage to Q1 Scientific allows customers to allocate their in-house scientific and engineering resources for key strategic projects.

The Benefits of Outsourcing There is a significant argument for the outsourcing of stability storage: it requires significant capital investment; the chambers cover a large footprint of valuable production space; companies incur 24/7 monitoring and security costs, as well as ever increasing regulatory standards. Outsourcing this function can: ● Reduce and control costs: the Q1 Scientific ‘Pay for Use’ model eliminates waste and unseen maintenance, service and security costs, with no unexpected facility costs; ● Focus on Priority: companies can concentrate on core activities central to the business, focusing on activity not infrastructure; ● Transform CAPEX to OPEX: Reduction in capital investment in storage facilities and infrastructure and optimising utilisation and ROI on existing stability infrastructure; ● Flexible Capacity: Q1 Scientific’s capacity flexibility can flex with your requirements, making sure you have access to the amount of storage you need as and when required; ● Manage Risk and Compliance: Q1 Scientific offers a primary or contingency storage solution and disaster recovery capability.

The company provides stability storage across all environmental conditions, with walk-in chambers, each validated for specific temperature and humidity conditions, controlled to +/- 2°C and 5% relative humidity. Additionally, available are reach-in 20°C freezers, ultra low temperature freezers, biorepositories and photo stability chambers. Q1 Scientific was named Start-Up Company of the Year at this year’s Pharmaceutical Industry Awards.

Q1 Scientific provides stability storage across all environmental conditions, with walk-in chambers, each validated for specific temperature and humidity conditions, controlled to +/- 2°C and 5% relative humidity.

About Q1 Scientific The Q1 Scientific name derives from the ICH Stability Guidelines ICH Q1: (For reference: guidelines range from ICH Q1 A to ICH Q1 F) and the facility operates to GMP at EU, US and international standards. Irish PharmaChem | Industry Buyers Guide 2016

Flow Measurement

Proline 100: Flow Measurement in a Compact Design Competition is fierce, whether you’re in the life science, chemical or biotechnology industries, and it’s no surprise that more companies are looking for a way to gain a competitive advantage. Businesses are able to implement their processes in a shorter time by following a ‘modular principle’. This modular principle requires devices to be fitted into a minimum of space, with customers requiring more compact devices, without limiting functionality. The Proline 100 range from Endress+Hauser was specifically designed for such applications. Endress+Hauser’s Proline 100 devices combine proven sensor technology with ultra-compact transmitter technologies, without any compromise. Operation for Proline 100 devices is through a standard web browser and all Proline four-wire devices feature an integrated web server. There is no special equipment or software needed, meaning less investment, less time and a fast and easy connection. The Proline 100 range features permanent self-diagnostics from Heartbeat Technology, Endress+Hauser’s reliable self-monitoring for all Proline measurement technologies, and a service-friendly data storage

concept (HistoROM) guarantees safe operation around the clock. Proline 100 devices feature seamless system integration via HART, Modbus RS485 or EtherNet/IP. The Proline 100 series design is optimised for applications requiring hygienic conditions and optimal clean ability. Based in Kildare, Endress+Hauser Ireland has over 30 years’ experience in industrial measurement instrumentation and automation solutions. Thanks to the company‘s expertise and continuous development, Endress+Hauser Ireland offers to its customers a wide range of products and services and tailor made solutions. For more information, call (045) 989200 or email info@ie.endress.com.

Benefit from simple operation and seamless integration from Endress+Hauser’s Proline 200 family - the first standardized concept for two-wire flowmeter devices. Our Proline 200 range is a world first with a standard concept for two-wire flowmeter devices, offering a 4-20mA loop-powered integration. Available for coriolis, electromagnetic, ultrasonic and vortex flow technologies.

Benefits of Two-Wire Flow •

• •

Two-wire technology standard practice in field instrumentation Cost benefits of using existing infrastructure Two-Wire can easily be replaced without additional wiring work Seperate power supply not necessary Maintenance work possible even during operation Higher plant availability and greater flexibility High level of operational safety via intrinsically

•

Potentially less hazardous due to small voltage

• • • •

safe EEx-ia ATEX concept

and currents

Seamless Intergration.

For more information please see our website www.ie.endress.com or call us on 045 989 200. Endress+Hauser (Ireland) Ltd. Tel: 00353 45 989 200 Fax: 00353 45 868 182 Exchequer House, info@ie.endress.com Embassy Office Park, Kill, Co. Kildare

Irish PharmaChem | Industry Buyers Guide 2016

Bulk Packaging

Fibre Drums – Sustainable, Safe, Certified Versatile, cost effective and sustainable, Fibre Drums are ideal bulk packaging options for the pharma industry in Ireland. Manufactured in Ireland using kraft fibre, produced from sustainable forests and requiring a fraction of energy to produce compared with other materials, Fibre Drums are amongst the most cost-effective and sustainable bulk packaging options available to the pharma industry in Ireland. With recent

advances in production technology and liners, Fibre Drums have become more versatile than ever. Progressive Packaging Professionals are now updating their view of Fibre Drums in terms of their use and performance. However, there are a few misconceptions that still exist.

Three Myths about Fibre Drums Dispelled Myth one: Fibre Drums cannot be used for dangerous goods. This is simply not Certification for true. Fibre Drums have dangerous goods in PG I,II & III, as well as a “V” rating required for packing “Lab Smalls”. Myth two: Fibre Drums cannot be used for moisture sensitive products? Wrong. Fibre Drums can be lined internally with integrated Alufoil to prevent water vapour, oxygen and UV ingress. This has the added benefit of extending shelf life significantly. After stability trial research in 2015, a leading Irish excipient producer increased product shelf life by 100% relative to Standard Drums, Corrugated Boxes and FIBC’s.

Fibre Drums can be lined internally with integrated Alufoil to prevent water vapour, oxygen and UV ingress

Fibre Drums: cost effective, versatile and sustainable bulk packaging options. For more information, contact: Rob Lee, Industrial Packaging Ltd, Dangerous Goods Safety Advisor. Tel: +353 (0)1 2864010. Email: rob@industrialpackaging.ie Web: www.industrialpackaging.ie Irish PharmaChem | Industry Buyers Guide 2016

Myth three: Fibre Drums shouldn’t be used in cleanrooms. With an integrated internal and external liner or lacquer, the PharmaKleen Fibre Drum has been developed specifically for Cleanroom and GMP production areas.

The PharmaKleen Fibre Drum has been developed specifically for Cleanroom and GMP production areas.

Waste Management

Sustainable Waste Solutions from Indaver

total waste management solutions to offer customers the lowest total cost of ownership. Indaver’s European network of hazardous waste processing facilities and strong data management systems ensures the flexibility to meet customers’ needs and the ability to provide full traceability from the point of collection to final disposal. Customers also have secure access to their own online reports.

Assets in Ireland

Indaver’s Solvent Recovery Facility in their Hazardous Waste Transfer Station in Dublin Port. Indaver’s Total Waste Management service is designed to meet the needs of large international industrial companies, primarily from the pharmaceutical and chemical sectors. Indaver manages all waste streams generated on the customer’s site in accordance with the EU waste hierarchy. Regular reviews ensure waste management services are optimised in a cycle of continuous improvement. ISO accredited for over 10 years, Indaver provides full compliance with Irish, UK, EU environmental and health & safety legislation and all relevant

ADR and IMDG transport legislation.

European Network Indaver, a leading European waste management company, has been established in Ireland since 1977. Their core business is running specialised facilities and managing intelligent waste management systems, focusing on sustainable material and energy management. With over 30 years’ experience, Indaver has the expertise to provide sustainable, cost effective and tailored

Indaver’s facilities in Ireland include the EPA licensed Dublin Port Hazardous Waste Facility, incorporating a transfer station, a laboratory and a state-of-the-art solvent recovery facility. Indaver has constructed Ireland’s first wasteto-energy facility in Duleek, Co. Meath. The €140 million facility has been operating since August 2011, and is helping Ireland meet its EU and national objectives by diverting waste away from landfill and up the waste hierarchy to recovery. The company recently received permission allowing for an additional 10% capacity to treat hazardous waste. This brings to 235,000 tonnes the amount of waste that will be turned into energy for the equivalent of more than 20,000 homes. The waste-toenergy facility in Meath, which in hazardous waste, is the first of its kind in Ireland. Indaver is committed to providing Irish industry with secure, cost-effective and sustainable waste solutions.

Irish PharmaChem | Industry Buyers Guide 2016

CHEMICAL SUPPLIERS

2 0 1 2

Acids & alkalis Associated Chemicals Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd Chemsource Industrial Division Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Goulding Chemicals Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd Q1 Scientific SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar B.V.

Activated carbons Associated Chemicals Ltd

biochemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

biocides Associated Chemicals Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd Univar B.V.

catalysts Associated Chemicals Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd

Irish PharmaChem | Industry Buyers Guide 2016

chiral compounds Associated Chemicals Ltd Camida Ltd National Chemical Company

excipients Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd Univar B.V.

fine chemicals Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd P.K. Chemicals Ltd Solv-Echem Ireland Ltd Univar B.V.

gases Corcoran Chemicals Limited National Chemical Company

heterocyclics Associated Chemicals Ltd Camida Ltd National Chemical Company

inorganic chemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Fisher Scientific Ireland Ltd Heterochem Dist Ltd

Langanbach Services Ltd National Chemical Company P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar B.V.

laboratory reagents Brenntag Ireland Corcoran Chemicals Limited Fisher Scientific Ireland Ltd National Chemical Company Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Water Chromatography Ireland

Misc chemicals Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Chemsource Industrial Division Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar B.V.

oils fats and waxes Associated Chemicals Ltd Brenntag Ireland Charles Tennant & Co Ltd Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd Univar B.V.

organic intermediates Associated Chemicals Ltd Brenntag Ireland

CHEMICAL SUPPLIERS

Camida Ltd Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd National Chemical Company Univar B.V.

organometallics Associated Chemicals Ltd Camida Ltd Corcoran Chemicals Limited National Chemical Company

reagents Associated Chemicals Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd National Chemical Company Ocon Chemicals Ltd

SciChem - Cork SciChem - Dublin Water Chromatography Ireland

silanes Associiated Chemicals Ltd Brenntag Ireland Camida Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Univar B.V.

solvents Betco Marketing Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd Chemsource Industrial Division

Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Teva Pharmaceuticals Ireland Univar B.V. Water Chromatography Ireland

surfactants Associated Chemicals Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Corcoran Chemicals Limited Heterochem Dist Ltd Langanbach Services Ltd National Chemical Company Univar B.V.

www.irishpharmachem.com Manufacturing in Ireland since 1947

Specialists in Dangerous Goods Bulk Packaging Fibre, Plastic & Steel Drums, IBCâ&#x20AC;&#x2122;s, FIBCS, UN Boxes, Buckets and Jerricans

For more information, contact:

Rob Lee, Industrial Packaging Ltd, Dangerous Goods Safety Advisor. Tel: +353 (0)1 2864010. Email: rob@industrialpackaging.ie Web: www.industrialpackaging.ie 50

Irish PharmaChem | Industry Buyers Guide 2016

GENERAL SUPPLIERS

2 0 1 2

Actuators Tyco Valves & Controls Ireland Ltd WrenTech Ltd

Aerators WrenTech Ltd

Agitators CPI Technology Ltd WrenTech Ltd

air filtration / monitoring / pollution control SciChem - Cork SciChem - Dublin

ALARMS P.J. Bonner & Company

ALUMINIUM PRODUCTS SteriPack

ANALYSIS SERVICES Anecto Catalent Pharma Solutions Indaver Ireland Lancaster Laboratories

Associations GS1 Ireland

ANALYTICAL EQUIPMENT ABB Ltd Fisher Scientific Ireland Ltd LABPLAN P.J. Bonner & Company SciChem - Cork SciChem - Dublin

AUTOCLAVES Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

AUTOMATION ABB Ltd Callaghan Engineering LABPLAN O’Flynn Medical Ltd P.J. Bonner & Company Weber Packaging Solutions Ltd

Irish PharmaChem | Industry Buyers Guide 2016

BALANCES Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P.J. Bonner & Company SciChem - Cork SciChem - Dublin

BARCODING / LABELLING TRACEABILITY GS1 Ireland Indaver Ireland Millmount Healthcare Weber Packaging Solutions Ltd

Biopharmaceuticals Alkermes Pharma Ireland Limited

BIOTECHNOLOGY ABB Ltd Callaghan Engineering Catalent Pharma Solutions Labplan Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin

BLENDERS Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

BLISTERING / DE-BLISTERING Catalent Pharma Solutions SteriPack

BLOWERS CPI Technology Ltd Flexachem Manufacturing Ltd

BPRV BS&B Safety Systems Ltd

BURSTING / RUPTURE DISCS BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

CABINETS ProSys Containment and Sampling Technology Sartorius Mechatronics Weber Packaging Solutions Ltd

CAD Callaghan Engineering

CALIBRATION Endress & Hauser (Ireland) Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company Sartorius Mechatronics Veolia Water Chromatography Ireland

CENTRIFUGES CPI Technology Ltd Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd Sartorius Mechatronics SciChem - Cork SciChem - Dublin

CHEMICAL CONSULTANTS Callaghan Engineering

CHROMATOGRAPHY Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin Water Chromatography Ireland

CLEANROOMS Callaghan Engineering Millmount Healthcare Ocon Chemicals Ltd Veolia

CLEANING SERVICES / EQUIPMENT WrenTech Ltd

COLD CHAIN PACKAGING Catalent Pharma Solutions CRS Pharma Solutions Millmount Healthcare Quitmann O’Neill

49 51

GENERAL SUPPLIERS COMPRESSED AIR / COMPRESSORS Festo Ltd Idex Pump Technologies (Ireland) Ltd Veolia

COMPUTER SYSTEMS Premier Validation Weber Packaging Solutions Ltd

CONDENSORS CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

CONDITION MONITORING Flexachem Manufacturing Ltd P.J. Bonner & Company Q1 Scientific Veolia

CONSTRUCTION MANAGEMENT Callaghan Engineering Portakabin Allspace

Contract Pharma Services Alkermes Pharma Ireland Limited

CONVEYORS Weber Packaging Solutions Ltd WrenTech Ltd

COOLING SYSTEMS CPI Technology Ltd Cross Technical Solutions Veolia

DATA ACQUISITION ABB Ltd Endress & Hauser (Ireland) Ltd Labplan P.J. Bonner & Company Weber Packaging Solutions Ltd

DESIGN Callaghan Engineering Cross Technical Solutions Graham Hart (Process Technology) Ltd Pilz Ireland Quitmann O’Neill SteriPack

DiSPERSERS Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Quitmann O’Neill WrenTech Ltd

50 52

DISTILLATION CPI Technology Ltd Fisher Scientific Ireland Ltd Graham Hart (Process Technology) Ltd Labplan Ocon Chemicals Ltd Soltec (Ireland) Ltd

DRIERS CPI Technology Ltd

DRUMS / CONTAINERS Carbon Group Chemco Ireland Ltd Complas Packaging Ltd Indaver Ireland Industrial Packaging Ltd Interpac Ocon Chemicals Ltd Quitmann O’Neill WrenTech Ltd

EDUCATION & TRAINING CPI Technology Ltd Euraxess GS1 Ireland HRB Clinic Research Facility McGee Pharma International Pilz Ireland Science Foundation Ireland (SFI) Water Chromatography Ireland

EFFLUENT MONITORING TREATMENT Carbon Group Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Lancaster Laboratories P.J. Bonner & Company Veolia

ELECTRICAL Callaghan Engineering P.J. Bonner & Company Veolia

ELECTRONIC COMPONENTS Pilz Ireland

ENERGY EFFICIENCY / MANAGEMENT Berkley Group Callaghan Engineering Endress & Hauser (Ireland) Ltd Sustainable Energy Authority of Ireland Veolia

ENGINEERING SERVICES Berkley Group Callaghan Engineering Cross Technical Solutions Henley Forklift Group Limited Pilz Ireland P.J. Bonner & Company Veolia

ENVIRONMENTAL CONSULTING ABB Ltd Callaghan Engineering Pilz Ireland Veolia

ENVIRONMENTAL SERVICES/ EQUIPMENT ABB Ltd Indaver Ireland Interpac Pilz Ireland P.J. Bonner & Company

EVAPORATORS Cross Technical Solutions Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Labplan

EXHIBITION DESIGN & DISPLAY Clip Ltd Ireland

EXPLOSION PROOFING Henley Forklift Group Limited Pilz Ireland Sartorius Mechatronics

EXPLOSION PROTECTION / PANELS BS&B Safety Systems Ltd CPI Technology Ltd Henley Forklift Group Limited Pilz Ireland

FACILITY DESIGN Callaghan Engineering

FACILITIES MANAGEMENT Hochtief Facility Management Portakabin Allspace Quitmann O’Neill

FILLING EQUIPMENT Interpac Quitmann O’Neill WrenTech Ltd

FILTERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Ocon Chemicals Ltd Irish PharmaChem | Industry Buyers Guide 2016

GENERAL SUPPLIERS FILTRATION Associated Chemicals Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

FLOW CONTROL CPI Technology Ltd Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

FLUID HANDLING CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd Labplan SciChem - Cork SciChem - Dublin WrenTech Ltd

FUME CUPBOARDS Fisher Scientific Ireland Ltd Interpac Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

FURNACES SciChem - Cork SciChem - Dublin

GAS DETECTION Cross Technical Solutions Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin

GAUGES Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P.J. Bonner & Company

GLASSWARE Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Quitmann O’Neill SciChem - Cork SciChem - Dublin

GRINDING CPI Technology Ltd

Irish PharmaChem | Industry Buyers Guide 2016

HAZARDOUS WASTE DISPOSAL / TREATMENT Idex Pump Technologies (Ireland) Ltd Indaver Ireland Industrial Packaging Ltd Interpac Ocon Chemicals Ltd Quitmann O’Neill Soltec (Ireland) Ltd Veolia

HEALTH & SAFETY / FIRST AID Ocon Chemicals Ltd Pilz Ireland

HEAT EXCHANGERS CPI Technology Ltd Graham Hart (Process Technology) Ltd Labplan ProSys Containment and Sampling Technology

HOMOGENISERS CPI Technology Ltd Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

HOSES CPI Technology Ltd

HYDRAULICS Henley Forklift Group Limited WrenTech Ltd

INCINERATION Indaver Ireland Tyco Valves & Controls Ireland Ltd

INCUBATORS Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

INJECTION MOULDING Allstop Europe Ltd

INSPECTION EQUIPMENT Lister Machine Tools Ltd P.J. Bonner & Company Sartorius Mechatronics Weber Packaging Solutions Ltd

Ocon Chemicals Ltd P.J. Bonner & Company SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd Veolia

IT Callaghan Engineering Weber Packaging Solutions Ltd

INVESTMENT Goodbody Stockbrokers

INVESTMENT promotion ageny IDA Ireland

lab equipment / supplies Carbon Group Labplan Ocon Chemicals Ltd P.J. Bonner & Company Solv-Echem Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

legal / financial / insurance Goodbody Stockbrokers Quitmann O’Neill

logistics C&G Logistics Group KWE (Ireland) Ltd Quitmann O’Neill Solv-Echem Ireland Ltd Weber Packaging Solutions Ltd

lifts & hoists Henley Forklift Group Limited WrenTech Ltd

machine tools Lister Machine Tools Ltd Soltec (Ireland) Ltd

maintenance CPI Technology Ltd Hochtief Facility Management Sartorius Mechatronics UK Ltd Veolia Water Chromatography Ireland Weber Packaging Solutions Ltd

INSTRUMENTATION

manUfacture

ABB Ltd Callaghan Engineering Endress & Hauser (Ireland) Ltd Labplan

Portakabin Allspace Sartorius Mechatronics

49 53

GENERAL SUPPLIERS materials handling / forklifts / pallet trucks Henley Forklift Group Limited Toyota Material Handling Ireland Ltd Weber Packaging Solutions Ltd WrenTech Ltd

mechanical engineering services Berkley Group Callaghan Engineering CPI Technology Ltd Cross Technical Solutions Henley Forklift Group Limited Pilz Ireland Tyco Valves & Controls Ireland Ltd Veolia Weber Packaging Solutions Ltd

mechanical & process engieering Callaghan Engineering CPI Technology Ltd Tyco Valves & Controls Ireland Ltd Veolia Weber Packaging Solutions Ltd

medical device manufacture B. Braun Medical

membrane filtration systems MICROFILTRATION: Fisher Scientific Ireland Ltd Merck Millipore NANOFILTRATION: Merck Millipore Ocon Chemicals Ltd Fisher Scientific Ireland Ltd Ultrafiltration: Merck Millipore Ocon Chemicals Ltd Reverse osmosis: Merck Millipore Ocon Chemicals Ltd

Meters CPI Technology Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Veolia

microscopes

SciChem - Cork SciChem - Dublin

milling CPI Technology Ltd WrenTech Ltd SciChem - Cork SciChem - Dublin

mixers CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd WrenTech Ltd

noise / odour control Associated Chemicals Ltd Flexachem Manufacturing Ltd

oem manufacturing Anecto B. Braun Medical Idex Pump Technologies (Ireland) Ltd Tyco Valves & Controls Ireland Ltd

Pipes / Cores CPI Technology Ltd Flexachem Manufacturing Ltd Smurfit Kappa Ireland

Plastic Containers Carbon Group Fisher Scientific Ireland Ltd Measom Freer Medisize Ireland Ltd Interpac Ocon Chemicals Ltd PrimePac Ltd Quitmann O’Neill SciChem - Cork SciChem - Dublin

Plastic Cores / Tubes Ocon Chemicals Ltd Quitmann O’Neill Smurfit Kappa Ireland

Pneumatics Flexachem Manufacturing Ltd P.J. Bonner & Company

Pollution Control Callaghan Engineering Veolia

packaging / design Anecto Catalent Pharma Solutions Charles Tennant & Co Ltd Complas Packaging Ltd Industrial Packaging Ltd Interpac Limerick Packaging Quitmann O’Neill SteriPack Weber Packaging Solutions Ltd

packaging / machinery Interpac Millmount Healthcare NPP Group Ltd Limerick Packaging Quitmann O’Neill Smurfit Kappa Ireland Weber Packaging Solutions Ltd WrenTech Ltd

pallets Interpac Limerick Packaging Quitmann O’Neill

Pharmaceutical Fabrication

Powder Handling Carbon Group CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd Industrial Packaging Ltd Interpac ProSys Containment and Sampling Technology Quitmann O’Neill Tyco Valves & Controls Ireland Ltd WrenTech Ltd

Pressure measurements / Switches / Vessels BS&B Safety Systems Ltd Flexachem Manufacturing Ltd

Pressure Relief BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Pilz Ireland Tyco Valves & Controls Ireland Ltd

pressure vessels CPI Technology Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

Tyco Valves & Controls Ireland Ltd

Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

50 54

Irish PharmaChem | Industry Buyers Guide 2016

GENERAL SUPPLIERS Print Packaging Contego Packaging Group SteriPack Interpac Limerick Packaging Quitmann O’Neill Weber Packaging Solutions Ltd

Process Control ABB Ltd Callaghan Engineering Endress & Hauser (Ireland) Ltd Pilz Ireland P.J. Bonner & Company Sartorius Mechatronics Tyco Valves & Controls Ireland Ltd

process design ABB Ltd Callaghan Engineering Pilz Ireland Tyco Valves & Controls Ireland Ltd

process & mechanical engineering contractors Pilz Ireland Tyco Valves & Controls Ireland Ltd

project management ABB Ltd Callaghan Engineering Pilz Ireland

REACTORS CPI Technology Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

recruitment Berkley Group Brightwater ICDS Recruitment Consultants Lancaster Laboratories Thornshaw Scientific Recruitment

refrigeration / freezing Cross Technical Solutions CRS Pharma Solutions Fisher Scientific Ireland Ltd Langanbach Services Ltd Q1 Scientific SciChem - Cork SciChem - Dublin Veolia

renewable energy ABB Ltd Callaghan Engineering Sustainable Energy Authority of Ireland Veolia

RESPIRATORY PHARMACEUTICALS Teva Pharmaceuticals Ireland

robotics Labplan

protective clothing / apparatUS Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

pumps CPI Technology Ltd Fisher Scientific Ireland Ltd Idex Pump Technologies (Ireland) Ltd Quitmann O’Neill Water Chromatography Ireland

Quality & compliance ABB Ltd McGee Pharma International Weber Packaging Solutions Ltd

r&d Euraxess Ireland Fisher Scientific Ireland Ltd Lancaster Laboratories SciChem - Cork SciChem - Dublin Synthesis and Solid State Pharmaceutical Centre TopChem Pharmaceuticals Ltd Tyco Valves & Controls Ireland Ltd Irish PharmaChem | Industry Buyers Guide 2016

solvent recovery / services Carbon Group CPI Technology Ltd Soltec (Ireland) Ltd

Stability Storage Q1 Scientific

stainless steel / fitting / products CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd Interpac National Chemical Company Quitmann O’Neill Tyco Valves & Controls Ireland Ltd WrenTech Ltd Weber Packaging Solutions Ltd

stEAM EQUIPMENT CPI Technology Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

storage / bunding CRS Pharma Solutions Interpac Quitmann O’Neill SciChem - Cork SciChem - Dublin

storage of hazardous materials C&G Logistics Group

sanitary tubing CPI Technology Ltd Flexachem Manufacturing Ltd

scada / dcs / mis ABB Ltd Callaghan Engineering P.J. Bonner & Company

scrubbers Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

seals & gaskets Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

sieving Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Particular Sciences Ltd WrenTech Ltd

software Sartorius Mechatronics

supply chain management C&G Logistics Group Catalent Pharma Solutions GS1 Ireland KWE (Ireland) Ltd Limerick Packaging National Chemical Company Solv-Echem Ireland Ltd

tableting equipment Flexachem Manufacturing Ltd WrenTech Ltd

tanks Celtic Forwarding Ltd Complas Packaging Ltd Flexachem Manufacturing Ltd Quitmann O’Neill

temperature control Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Labplan Ocon Chemicals Ltd

49 55

GENERAL SUPPLIERS Flexachem Manufacturing Ltd WrenTech Ltd

valves

temporary lab & office accomModation testing services

transport & logistics Contact: National Sales C&G LogisticsManager: Group Celtic Forwarding Ltd Davnet Donnelly Henley Forklift Group Limited KWE (Ireland) Ltd National Chemical Company Quitmann O’Neill Weber Packaging Solutions Ltd weber LAbeLLinG & codinG

Address: Kilcannon Ind. Est., tube sets / disposables Old Dublin Road, Fisher Scientific Ireland Ltd Enniscorthy, Langanbach Services Ltd Co. Wexford. Ltd Tel: Ocon Chemicals (053) 923 3778 Fax: (053) 923 3284 Email: sales@weberireland.com vacum systems Web: www.webermarking.ie CPI Technology Ltd Contact: Operations Manager: Fisher Scientific Ireland Ltd Patrick Hughes

washing equipment

CPI Technology Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd WrenTech Ltd

Portakabin Allspace

Anecto CPI Technology Ltd Henley Forklift Group Limited Lancaster Laboratories P.J. Bonner & Company SteriPack

Quitmann O’Neill Weber Packaging Solutions Ltd

Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

validation ABB Ltd Callaghan Engineering rIsh harma Cross Technical Solutions hem Pilz Ireland McGee Pharma International Lancaster Laboratories wren tech Ltd

waste management / balers /recycling

2012

Address: Eversley, ventilation Church Bay Road, Callaghan Engineering Crosshaven, Pilz Ireland Co. Cork. Tel: (021) 483 2644 Veolia Fax: (021) 483 1363 Email: smurray@wrentech.ie vision systems Web: www.wrentech.ie Weber Packaging Solutions Ltd Contact: Sales Administrator: Siobhan Murray

warehouse management

Interpac Ocon Chemicals Ltd Quitmann O’Neill Veolia

water treatment Carbon Group Chemco Ireland Ltd zFisher etes ireLAnd Scientific Ireland Ltd Address: The National Flexachem Manufacturing Ltd Industrial PackagingTechnological Park, Ltd Limerick. Ocon Chemicals Ltd Tel: (061) 333 188 Tyco Valves & Controls Ireland Ltd Fax: (061)333 133 Veolia Email: sales@ie.zetes.com

Web: weighing Business:

www.zetes.ie Auto ID software and P.J. Bonner & Company hardware including barcode label printers, Sartorius Mechatronics print & apply, hand held SciChem - Cork SciChem - Dublin computers, serialisation & warehouse inventory Weber Packaging Solutions Ltd solutions. Contact: Business Development www.irishpharmachem.com Manager: Barry Long C&G Logistics Group Celtic Forwarding Ltd Chemsource Industrial Division Chemsource Logistics Complas Packaging Ltd Portakabin Allspace

Notes

50 56

Irish PharmaChem | Industry Buyers Guide 2016

ComPany LIstIngs

P.J. Bonner & Company Tyco Valves & Controls Ireland Ltd Q1 Scientific

COMPANY LISTINGS

2 0 1 2

ABB Ltd Address: Belgard Road, Tallaght, Dublin 24. Tel: (01) 405 7300 Fax: (01) 405 7327 Email: marketing@ie.abb.com Web: www.abb.ie Business: Lifescience solutions. Analytical Equipment, Automation, Biotechnology, Data Acquisition, Environmental Consulting Environmental Services / Equipment, Instrumentation, Process Control, Process Design, Project Management, Quality & Compliance, Renewable Energy, SCADA / DCS / MIS, Validation.

Alkermes Pharma Ireland Limited Global. Diversified.

Address: Monksland, Athlone, Co. Westmeath. Tel: (090) 649500 Web: www.alkermes.com Business: Global Biopharmaceutical Company. Contact: Vice President & Athlone General Manager : Kevin Brady

allsop europe ltd

BETCO MARKETING LTD

Address: Industrial Park, Waterford. Tel: 353 51 355091 Fax: 353 51 377717 Email: noel.kinsella@allsop.eu Web: www.allsopmould.ie Business: Injection moulding products. Contact: Manufacturing & Quality Manager: Noel Kinsella

Address: Exham House, The Fingerpost, Douglas, Co. Cork. Tel: (021) 436 4999 Fax: (021) 436 5739 Email: dhalpin@betco.ie Web: www.betco.ie Contact: Managing Director: Diarmuid Halpin

anecto Address: Mervue Business Park, Co. Galway. Tel: (091) 757 404 Fax: (091) 757 387 Email: sales@anecto.com Web: www.anecto.com Business: Dangerous goods packaging testing laboratory.

ASSOCIATED CHEMICALS LTD Address: 16D Euro Business Park Little Island, Co. Cork. Tel: (021) 435 1014 Fax: (021) 435 1015 Email: info@acl.ie Business: Chemical Suppliers & Distributors Contact: Managing Director: Sylvester Cotter

BERKLEY GROUP Transformative.

Address: Dublin: 509 The Capel Building, Maryâ&#x20AC;&#x2122;s Abbey, Dublin 7. Cork: Mill House, Carrigrohane, Co. Cork. International Offices: Singapore, London & Dubai. Tel: (01) 872 4666 (021) 428 9600 Email: sgreenwood@Berkley-group.com Web: www.berkley-group.com Contact: Steve Greenwood

Irish PharmaChem | Industry Buyers Guide 2016

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary

P.J. BonNer & Company Instrumentation & Weighing Specialists Address: 35 Western Parkway Business Centre, Ballymount Drive, Ballymount, Dublin 12. Tel: (01) 450 5050 Fax: (01) 450 5183 Email: info@pjbonner.com Web: www.pjbonner.com Business: Instrumentation & Weighing Specialists. Calibrations and Product Sales. Contact: Managing Director: Patrick M Bonner Service Manager: Roddy Jefferson Weighing Sales: Kenny Syder Instrumentation Sales: Thomas McDonnell

57 49

COMPANY LISTINGS

catalent pharma solutions

Address: Mobile: Fax: Email: Web: Business: Contact:

3 Naas Road Industrial Park, Dublin 12. 086 833 9836 +353 (0)1 709 1889 robert.bannon@bbraun.com www.bbraun.ie OEM manufacturing. Sales Consultant Robert Bannon

C+G LOGISTICS GROUP Address: Westpoint Business Park, Navan Road, Mulhuddart, Dublin 15. Tel: (01) 820 8455 Fax: (01) 820 8457 Email: info@cglogistics.ie Web: www.cglogistics.ie Contact: General Manager/ rIsh harma hem Director: Patrick Wogan Business Development Manager: Duncan Breen

2012

Building 1000,

Units 1201& 1202, CALLAGHAN ENGINEERING

b renntAG ireLAnd Brenntag Ireland

Address: Unit 405, Address: Unit 405, Greenogue Greenogue Business Business park, Rathcoole, Park, Rathcoole, Dublin 24. Tel: Dublin 24. (01) 401 3500 Tel: (01) 401 3500 Fax: (01) 405 3501 Fax: (01) 405 3501 Email: dublin.sales@brenntag.ie Email: dublin.sales@brenntag.ie Web: www.brenntag.ie Web: www.brenntag.ie Business: Chemical Suppliers & Contact: Sales Desk Distributors Contact:

Sales Desk.

briGhtwAter Address: 36 Merrion Square, BRIGHTWATER

Address: 36Dublin 2. Merrion Square, Dublin 2. Tel: (01) 662 1000 Tel: (01) 662 1000 Fax: (01) 662 3900 Fax: (01) 662 3900 Email: e.moloney@brightwater.ie Email: b.mcgrath@brightwater.ie Web: www.brightwater.ie Web: www.brightwater.ie Contact: Eileen Moloney Contact: Barbara McGrath,

Deputy Managing

bs&b sAfety systems Ltd Director

Address: Raheen Business Park, BS&B SAFETY Raheen, SYSTEMS LTD Co. Limerick. Address: Bay G1, Raheen Business Tel: (061) 484 700 Park, Raheen, Co. Limerick. Tel: Emergency Delivery: (061) 484 700 Mobile: 086 241 0615 (086) 8385556 Fax: Direct Line: (061) 227 987 Email: 086 838 5556 sales@bsb.ie Fax: (061) 352 240 Web: www.bsb.ie Email: sales@bsb.ie Business: Manufacturing /Safety Web: www.bsb.ie Devices Business: Pressure relief devices. Contact: Ireland Direct Sales Contact: Sales Manager: Manager: Patrick Murphy Patrick Murphy

Web: www.calleng.ie cAmidA Business: Ltd Multi-discipline Address: Tower House, consulting engineering andNew Quay, project managment Clonmel, company.

Â Co. Tipperary. Tel: (052) 612 5455 Fax: (052) 612 5466 Email: info@camida.com Web: CAMIDA LTD www.camida.com Contact: Company Secretary: Address: New Quay, Clonmel, Co.Deirdre McGrath Tipperary. Tel: (052) 612 5455 Fax: (052) 612 5466 Email: info@camida.com Web: www.camida.com Contact: Company Secretary: cArbon Group Deirdre McGrath

cALLAGhAn enGineerinG Dublin: Wentworth House,

Factory Cross,

Ringaskiddy, carbon group

Co. Cork. Address: Factory Cross, Tel: +353 (0)21 437 8988 Ringaskiddy, Co. Cork. Mobile: 086 2612 485 Tel: +353 (0)21 437 8988 Fax: Mobile: 086+353 (0)21 437 8950 2612 485 Email: carol.deegan@carbon.ie Fax: +353 (0)21 437 8950 sales@carbon.ie Email: carol.deegan@carbon.ie Web: www.carbon.ie sales@carbon.ie Business: Pharmachemicals. Web: www.carbon.ie Contact: Area Sales Manager: Business: Pharmachemicals. Carol Deegan Contact: Area Sales Manager:

Carol Deegan

cAtALent phArmA soLutions Address:

50 58 Address:

City Gate, Mahon, Dublin Address: Wentworth House, Cork. 19/20 Hogan Place, (021) 240 9099 Tel: Lower Grand Canal St, Fax: (021) 240 9009 Dublin 2. Email: mail@calleng.ie Cork Address: Suite 201, Building 1000, www.calleng.ie Web: Units 1201& 1202, Business: Multi-discipline City Gate, Mahon, Cork. Tel: (01)consulting engineering 661 4420 Fax: (01)and project managment 661 4424 company. Email: mail@calleng.ie

Address:

Tel: Fax:

Address: Unit 26, Cherry Orchard Industrial Estate, Dublin 10. Tel: (01) 620 0600 Email: diarmuid.wilson@catalent.com Web: www.catalent.com Business: Contract manufacturing capabilities as well as packaging and printed components to the pharmaceutical industry. Contact: Director of Business Development: Director of Business Contact: Diarmuid Wilson

Unit 26, Cherry Orchard Industrial Estate, Dublin 10. (01) 620 0600 (01) 626 2815

Development: Diarmuid Wilson Celtic Forwarding Ltd

Address: Dublin: Celtic House, Ltd ceLtic forwArdinG 30 Marlborough St., Dublin 1. Address: Dublin: Waterford: Belview Port, Celtic House, Slieverue, Co. Waterford 30 Marlborough Tel: (01) 865 6000 Street, (051) 851 821 Dublin 1. Fax: (01) 874 6745 (051)Waterford: 851 823 Belview Port, Email: info@celticfwd.ie Slieverue, Web: www.celticfwd.ie Co. Waterford. Business: Shipping

Tel:

(01) 865 6000

(051) 851 821 Charles Tennant & co Ltd

Fax: (01) 874 6745 Address: 71 Cookstown Ind Estate, (051) 851 823 Belgard Road, Tallaght, info@celticfwd.ie Email: Dublin 24. Web: www.celticfwd.ie Tel: (01) 451 4099 Business: Shipping. Fax: (01) 451 4702 Contact: Director: Email: jgrehan@ctennant.ie www.charlestennant.com Finbarr Cleary Web: Sales Manager: Business: Chemical and Packaging Gerald Kiernan supplier. DGSA Contact: Chemical Manager: Tank Division Jim Grehan

Manager: Patty deCourcey

c + G LoGistics Group Address:

Westpoint Business Park, Navan Road, Mulhuddart, Dublin 15. Tel: (01) 820 8455 Chemco Ireland Limited Fax: (01) 820 8457 Address: Unit 2, Stadium Business Park, info@cglogistics.ie Email: Ballycoolin, Cappagh, Dublin 11 Web: D11 www.cglogistics.ie X205 Tel:Contact: +353General Manager/ (0)1 8293600 Fax: +353Director: (0)1 8855029 Patrick Wogan Email: info@chemco.ie www.chemco.ie Business Development Web: Manager: Cormac Sarsfield Irish PharmaChem | Industry Buyers Guide 2016

ComPany LIstIngs

B. Braun MEDICAL

COMPANY LISTINGS

CLIP LTD IRELAND

CPI technology ltd

Address: Clip Ltd Ireland, Alexandra House, The Sweepstakes, Ballsbridge, Dublin 4 Tel: (086) 828 3620 Email: paul.smith@clipdisplay.ie Web: www.clipdisplay.ie Business: Exhibition and display equipment manufacture and service. Contact: Irish Sales Manager: Paul Smith

Address: Unit 5 Link Road, Business Park, Ballincollig, Co. Cork. Tel: (021) 487 4142 Fax: (021) 487 8764 Email: info@cpitechnology.com Web: www.cpitechnology.com Business: Providers of Process Equipment. Contact: Managing Director: Adrian Giltinan

complas packaging ltd

CROSS TECHNICAL SOLUTIONS

Address: Naas Industrial Estate, Dublin Road, Naas, Co. Kildare. Tel: (045) 874 088/9 Fax: (045) 874 090 Email: sales@complas.ie Web: www.complas.ie

contego packaging croup healthcare Address: Unit 629, IDA Industrial Park, Northern Extension, Old Kilmeaden Road, Waterford. Tel: (051) 595 300 Fax: (051) 595 309 Email: sales.ireland@contegopackaging.com Web: www.contegopackaging.com Business: Carton & leaflet suppliers to the pharmaceutical industry.

CORCORAN CHEMICALS LIMITED Address: Tel: Fax: Email: Web: Business: Contact:

17 Parkgate Street, Dublin 8. (01) 633 0400 (01) 679 3521 info@corcoranchemicals.com www.corcoranchemicals.com Distribution Sales Department

Address: Unit 26, Second Avenue, Cookstown Industrial Estate, Cookstown, Tallaght, Dublin 24. Tel: (01) 405 6777 Fax: (01) 413 6932 Email: jmcgrath@crosstechnicalsolutions.ie Web: www.crosstechnicalsolutions.ie Business: Refrigeration Contact: Technical Director: Jonathan McGrath General Manager: Jason Keating

CRS Pharma Solutions Address: Tel: LoCall: Email: Web: Business: Contact:

Irish PharmaChem | Industry Buyers Guide 2016

Dublin, Belfast, London, Manchester. +353 46 943 5000 1890 929 824 info@crspharmasolutions.ie www.crspharmasolutions.ie GxP Compliant Pharmaceutical Portable Storage Solutions, temperature range from -65°C to +60°C 2-8 Degree Cold Stores, Close Control Freezer Stores, Hot Boxes, Incubators, Blast Chillers/ Freezers, Commissioning and Validation Team in-house, IQ, OQ, PQ Validation including Empty and Full thermal Mapping studies. Technical Director: Patrick Tyrrell

ENDRESS+HAUSER (IRELAND) LTD. Address: Tel: Fax: Email: Web: Business: Contact:

Exchequer House, Embassy Office Park, Kill, Co. Kildare. (045) 989 200 (045) 868 182 info@ie.endress.com www.ie.endress.com Leading supplier of products, services and solutions for industrial process measurement and automation industry. Sales Manager: Brian O’Connell

eurolec instrumentation ltd Address: Technology House, Cluan Enda, Dundalk, Co. Louth. Tel: (042) 933 3423 Fax: (042) 933 1758 Email: eurolec@esatclear.ie Web: www.eurolec-instruments.com Business: Electronic instrumentation.

EURAXESS IRELAND Address: C/O Irish Universities Association, 48 Merrion Square, Dublin 2. Tel: (01) 676 4948 Fax: (01) 662 2815 Email: jennifer.cleary@iua.ie Web: www.euraxess.ie Contact: Euraxess Ireland Manager: Jennifer Cleary

festo ltd Address: Tel: Fax: Email:

Unit 5, Sandyford Park, Sandyford Industrial Estate, Dublin 18. (01) 295 4955 (01) 295 5680 sales_ie@festo.com/ie

Web: Business:

www.festo.com/ie Automation company specialising in factory and process automation.

49 59

COMPANY LISTINGS

Goulding chemicals ltd

SCIENTIFIC fFISHER isher scientific IRELAND LTD Address: Suite 4, Plaza 212,

Suite 3, Plaza 212, Address: Blanchardstown Blanchardstown, Corporate Park 2, Corporate Park, Ballycoolin, Ballycoolin, Dublin 15. Dublin 15. Tel: (01) 885 5854 Tel: (01) 885 5854 Fax: (01) 899 1855 Fax: (01) 899 1855 Email: fsie.sales@thermofisher.com Email: fsie.sales@thermofisher.com Web: www.ie.fishersci.com Web: www.ie.fishersci.com Business: Laboratory Business: Laboratory supplies, supplies. Chemicals, Consumables, Contact: Marketing Reagents, Equipment & Instruments. Manager: Contact: Gerry Fitzmaurice Commercial

Product Manager:

f LexAcheMGerry Fitzmaurice MAnufActurinG Ltd

Address: Donnybrook flexachem Commercial Centre, manufacturing ltd Douglas, Co. Cork. Address: Donnybrook, Commercial Tel: (021) 461 7200 Centre, Douglas, Co. Cork. Fax: (021) 489 1297 Tel: (021) 461 7200 / (021) 4617209 Email: sales@flexachem.com Fax: (021) 489 1297 Web: www.flexachem.com Email: sales@flexachem.com Business: Manufacturer/ tim.quigley@flexachem.com Web: Distributor. www.flexachem.com Contact: Commercial Director: Business: Manufacturer/ Distributor. Contact: Agnes Mullins Operations Manager:

Tim Quigley

Goodbody Stockbrokers Address: Ballsbridge Park, Ballsbridge, Dublin 4. Tel: (01) 667 0400 G LAnbiA estAtes Fax: (01)Glanbia House, 667 0230 Address: goodbody@goodbody.ie Email: Ring Road, Web: www.goodbody.ie Co. Kilkenny. Business: Capital Markets, Tel: +353 (0) 87 256 4339 Investment Management, Email: gmullally@glanbia.com Wealth Management. Web: www.kilmeadenfields.com Contact: Portfolio Manager: Business: Property Business Kathryn Hannon

Contact:

50 60

Unit of Glanbia PLC. CEO: Ger Mullally

Address: Centre Park Road, hAzcheM trAininG Ltd hazchem training ltd Marina, Cork City. Address: G10, Maynooth Tel: 491 1611 Address: G10, Maynooth Business Campus, GoLiAth (021) pAckAGinG Fax:s ysteMs (021) Business Campus, Maynooth, Ltd491 1660 Email: kellyt@gouldings.ie Maynooth, Co. Kildare. Address: Beechwood, Nenagh, Web: www.gouldings.ie Tel: Co. Kildare. (01) 629 1800 Co. Tipperary. Business: Chemical distributor. Tel: (01) 629 1800 Fax: (01) 629 1822 Tel: (067) 37893 Fax: (01) 629 1822 Fax: (067) 34794 Email: info@hazchem.ie Graham Hart (Process Email: info@hazchem.ie Email: Ltd info@goliath.ie Web: www.hazchem.ie Technology) Web: www.hazchem.ie Contact: Director: Web: www.goliath.ie Address: Friars Industrial Estate, Contact: Director: Michelle Cleere Business: Supply & Bradford Road, Michelle Cleere installation of Idle, Bradford, packaging equipment henLey forkLift BD10 8SW, and materials Group Ltd UK. handling systems. Address: Henley Industrial Tel: (0044) 1274 617021 Contact: Director: Park, Killeen Road, Fax: (0044) 1274 618614 George O’Leary Dublin 10. Email: sales@graham-hart.com HENLEY FORKLIFT Tel: (01) 620 9200 Web: www.graham-hart.com GROUP LIMITED Business: Chemical Engineers Ltd Fax: (01) 626 5406 GouLdinG cheMicALs Address: Design and Henley Industrial Park, Email: fwilson@henley.ie Centre Park Road, Address: Manufacturers of Heat Killeen Road,phammett@henley.ie Dublin 10. Marina, Cork City. Tel: Exchangers and Process Tel: Web: (01) 620 9200 www.henley.ie (021) 491 1611 Plant. Fax: Business: (01) 626 5406 Forklifts & Fax: (021) 491 1660 Contact: Sales Director: Email: fwilson@henley.ie Warehousing Email: pollockm@gouldings.ie Stephen Hart Equipment. Web: www.gouldings.ie phammett@henley.ie Web: www.henley.ie Specialists in Business: Chemical Business: Forklift and flameproof forklift warehousing distributor. equipment, sales, service, trucks. hire, parts, driver training, Contact: Director: GrAhAM hArt thorough examinations. Mark Kenny (process technoLoGy) Ltd Contact: Director: Director: Address: Friars Ind. Estate, Brian O’Connell Brian O’Connell Ireland Bradford Road, GS1 boconnell@henley.ie Address: Second Idle, Bradford, Floor, The Merrion BD10 8SW, UK. hochtief fAciLity Centre, Nutley Lane, Tel: (0044) 1274 617021 M AnAGeMent Donnybrook, Dublin 4. Fax: (0044) 1274 618614 Address: Ireland: Tel: (01) 208 0660 Email: sales@graham-hart.com HOCHTIEF Facility Fax: (01) 208 0670 Web: www.graham-hart.com Management Email: info@gs1ie.org Web: Contact: www.gs1ie.org Sales Director: Ireland Ltd., Business: Global Supply Chain Stephen Hart Landscape House, Standards Body. Landscape Road, HETEROCHEM DIST LTD Contact: Chairman: John O’Callaghan Churchtown, Address: Unit 49, Vice Chairman: Tony Minogue Dublin 14. Robertson House, Chief Executive Officer: UK: Baldoyle Industrial Est., Mike Byrne HOCHTIEF Facility Dublin 13. Management UK Ltd, Tel: (01) 839 3127 Gs1 ireLAnd HOCHTIEF House, Fax: (01) 832 5746 Address: The Nutley Building, 2 Ibis Court, Email: info@heterochem.com Merrion Road, Web: Centre Park, www.heterochem.com Dublin 4. WarringtonWA1 1RL Business: Chemical Distributors Tel: (01) 208 0660 Tel: (01) 215 7000 & Raw Material Specialists. Fax: (01) 208 0670 +44 1925 404 500 Contact: Managing Director: Email: info@gs1ie.org Fax: (01) 215 7070 Kim Doran

Web: www.gs1ie.org +44 1925 404 598 Contact: Member Support Services: Email: Irish PharmaChem | Industry Buyers Guide 2016 Karen Murphy Web: www.hochtief-fm.ie 57

ComPany LIstIngs

IrIsh PharmaChem 2011

Business:

Materials Handling Equipment / Hyster Forklifts / Lancer Sideloaders General Manager: Conal McCourt

Contact:

irish nAtionAL AccreditAtion boArd, the

hochtief facility management Address: Tel: Fax: Web: Business:

Ireland: HOCHTIEF Facility Management Ireland Ltd., Landscape House, Landscape Road, Churchtown, Dublin 14. (01) 215 7000 (01) 215 7070 www.hochtief-fm.ie Facilities Management.

ICDS Recruitment Consultants Address: 24 Upper Fitzwilliam Street, Dublin 2. Tel: (01) 632 1200 Fax: (01) 676 2292 Email: info@icds.ie Web: www.icds.ie Business: Recruitment Consultants. Contact: Recruitment Director: Anthony McLoughlin

Address: Wilton Park House, Wilton Place, Dublin 2. Tel: (01) 607 3003 Fax: (01) 607 3109 Email: inab@inab.ie Web: www.inab.ie Business: Provides INDUSTRIAL PACKAGING accreditation LTD. Address: of laboratories, Killarney Road Business Park, certification & Bray, Co. Wicklow. Tel: inspection bodies. (01) 286 4010 Contact: Information Officer: Email: rob@industrialpackaging.ie Web: Orla Doyle www.industrialpackaging.ie Business:

Manufacturing of packaging Sales and Marketing Director: Rob Lee

J Contact:

JAvA cLinicAL reseArch Ltd Address:

Fitzwilliam Buiness Centre, 26 Upper Pembroke St, Dublin 2. Tel: 01 637 3903 Fax: 01 637 3907 Email: interpacinfo@javacr.com Web: www.javacr.com Address: 67E Heather Road, Sandyford Business: Clinical Research Industrial Estate, Contact: Managing Director: Sandyford, Dublin 18. Tel: Ruth Nallen (01) 294 0600 Fax: Email: Web:

(01) 294 0602 ian@interpac.ie www.interpac.ie

Fax: + 353 1 458 8015 Email: info@jol.ie niallh@jol.ie Web: www.johnstonlogistics.ie Business: Logistics & distribution (Complete Supply Chain Management). Contact: Business Development Manager: Niall Hickey

COMPANY LISTINGS

Contact:

KWE (Ireland) Ltd kwe (ireLAnd ) Ltd Controlled Dublin Head Office & Temperature

Address: Warehouse FacilityDublin: Unit 4 Horizon Logistics Address: Horizon Logistics Park Park, New Naul Rd, Harristown, Swords, Co Dublin Tel: Harristown, (01) 823 9600 Swords, Co. Dublin. Fax: (01) 836 1111 Email: Cork: Unit 4&5, kwedub@kwe.com South Ring dubsls@kwe.com Web: www.kwe.com West Business Pk, Cork Regional Office Tramore Road, & Warehouse Facility Address: Co. Cork. South Ring West, Business Park Tel: (01) 823 9600 Tramore Road, Cork. Tel: (021) 497 5722 (021) 497 5722 Fax: (01) 836 1111 Fax: (021) 497 5727 Email: (021) 497 5727 kweork@kwe.com Email: kwedub@ea.kwe.com kweork@ea.kwe.com Web: www.kwe.com L Contact: Sales Manager: LABPLAN Karl Oâ&#x20AC;&#x2122;Reilly Address:

LAbpLAn Tel:

invest northern ireland Address: Fax:

idex pump technologies (ireland) ltd

Address: Bedford Square, Bedford Street, Belfast, BT2 7ES. Tel: (048) 9069 8601 Fax: (048) 9043 6536 Email: patricia.oneill@investni.com Web: www.investni.com Business: Economic development agency.

Address: R79, Shannon Industrial Estate, Shannon, 52,63 Company Listings 2012.indd 7 Co. Clare. irish exporters Tel: (061) 471933 association - life Fax: (061) 475046 sciences ireland Email: vsicsipti@idexcorp.com Address: 28 Merrion Square, Dublin 2. Web: www.blagdonpump.com Tel: (01) 661 2182 www.vikingpump.com Fax: (01) 661 2315 Email: niallstobie@irishexporters.ie Contact: Customer Services: Web: www.irishexporters.ie Ann Oâ&#x20AC;&#x2122;Gorman Business: Life Sciences Ireland is Industry Grouping with the Irish Exporters Association. Contact: Manager Life Science Ireland: Niall Stobie.

Irish PharmaChem | Industry Buyers Guide 2016

Email: Web: Tel: Business: Fax: Email: Contact:

Tel: Fax: Email: Web: Business:

Allenwood Enterprise Park, Allenwood, Naas, Co Kildare. (045) 870 560 Allenwood Business (045) 870 811 Park, Allenwood, info@labplan.ie Naas, Co. Kildare. www.labplan.ie (045) 870 560 Lab supplier of analytical (045) 870 811 instrumentation, services, info@labplan.ie technical support. 58 Director: Managing Aidan Smyth

Eurofins Lancaster Laboratories Address: IDA Business Park, Clogherane, Dungarvan, Co. Waterford. Tel: (058) 48 300 Fax: (058) 42 855 Email: mglass@lancasterlabs.com Web: www.lancasterlabspharm.com Business: Contract Analytical Services. Contact: Business Development Director: Mark Glass

49 61

LAncAster L Address:

Tel: Fax: Email: i Web: www.la Business: Contact:

Lennox LAbo suppLies Ltd Address: Tel: Fax: Email: Web: Business:

COMPANY LISTINGS

langanbach services ltd

measom freer

Address: Tel: Fax: Email: Web: Business: Contact:

Unit 4, Cedar Estate, Killarney Road, Bray, Co. Wicklow. (01) 276 2510 (01) 276 2472 sales@langanbach.ie www.langanbach.ie Supply of laboratory equipment and diagnostic tests. Infection control products for human and animal health. Sales and Marketing Director: Jim Woods

lennox laboratory supplies ltd Address: John F. Kennedy Drive, Naas Road, Dublin 12. Tel: (01) 455 2201 Fax: (01) 450 7906 Email: sales@lennox.ie greg@lennox.ie Web: www.lennox.ie Business: Laboratory suppliers.

LISTER MACHINE TOOLS LTD Address:

PO Box 838, Bluebell Industrial Estate, Dublin 12. Tel: (01) 450 8866 Fax: (01) 450 9836 Email: sales@listermachinetools.com Web: www.listermachinetools.com Business: Sales and service of Machine Tools and related accessories, consumables and metrology equipment.

maclachlan & donaldson Address: 47 Merrion Square, Dublin 2. Tel: (01) 676 3465 Fax: (01) 661 2083 Email: mail@maclachlan.ie Web: www.maclachlan.ie Business: Intellectual Property Attorneys. Contact: Dr. Yvonne McKeown

LIMERICK PACKAGING Address: Eastlink Business Park, Ballysimon Rd., Limerick. Tel: 061-400035 Fax: 061-400036 Email: info@lmkpkg.ie Web: www.limerickpackaging.ie Business: Packaging manufacturers, Distributors, Designers and Auditors. Contact: Sales Director: Mike Boland

50 62

McGee Pharma International Address: 1st Floor, Stafford House, Strand Road, Portmarnock, Co. Dublin. Tel: (01) 846 4742 Fax: (01) 846 4898 Email: info@mcgeepharma.com Web: www.mcgeepharma.com Business: Pharmaceutical Quality, Technical & Compliance Specialist Consultancy. Contact: Jane Lyons

37-41 Charwell Drive, Wigston, Leicester, LE18 2FL, UK. (0044) 1162 881588 (0044) 1162 813000 sales@measomfreer.co.uk www.measomfreer.co.uk Manufacturer. Sales Director: Mark Freer

medisize ireland ltd Address: High Road, Letterkenny, Co. Donegal. Tel: (074) 918 8549 Email: info@medisize.com Web: www.medisize.com Business: Contract manufacturer of primary pharmaceutical packaging and medical and diagnostic devices. Contact: Business Development Manager: Marie Nelis

merck Address: Tullagreen, Carrigtwohill, Co. Cork. Tel: (021) 488 3666 Fax: (021) 488 3048 Email: martin.mcauliffe@merckgroup.com Web: www.merckmillipore.com Business: Life Science. Contact: Site Leader: Martin McAuliffe

micro Address: Unit 2003 Orchard Avenue, Citywest Business Campus, Dublin 24. Tel: (01) 463 9100 Email: info@mirco.ie Web: www.micro.ie Business: High Purity hose, manifolds / tube sets, disposable solutions for the Bio-Pharma Industry. Contact: Ralph Fitzsimons

Irish PharmaChem | Industry Buyers Guide 2016

COMPANY LISTINGS

NATIONAL CHEMICAL COMPANY Address: NCC House, 42 Lower Leeson St., Dublin 2. Tel: (01) 613 1400 Fax: (01) 634 0132 Email: sales@ncc.ie Web: www.ncc.ie Business: Supply Chain Partner Life Sciences Industry Contact: Sales Director: Christy Smith

npp group ltd Address: Unit 509, Mitchelstown Road, Northwest Business Park, Ballycoolin, Blanchardstown, Dublin 15. Tel: (01) 880 9299 Email: sales@npp.ie bmcmahon@npp.ie Web: www.npp.ie Business: Flexible packaging suppliers & distributors. Contact: Sales Director: Eoin McDonagh

o’flynn medical ltd Address: Tel: Fax: Email: Web: Business: Contact:

Westend, Millstreet, Co Cork. (029) 21 799 (029) 70 191 info@oflynnmedical.com www.oflynnmedical.com Distributor of Scrubex “Automated Protective Clothing Distributor”. Managing Director: Tadhg O’Flynn

OBEECO LTD Address:

Annaville Avenue,

Blackrock,

Co. Dublin.

Tel: Fax: Email: Web:

(01) 278 2323 (01) 278 2374 sales@obeeco.ie www.obeeco.ie

Irish PharmaChem | Industry Buyers Guide 2016

OCON CHEMICALS LTD

PORTAKABIN ALLSPACE

Address: Unit 5, South Cork Industrial Estate, Vicars Road, Pouladuff, Co. Cork. Tel: (021) 431 8555 Fax: (021) 431 8560 Email: info@oconchemicals.com Web: www.oconchemicals.ie Contact: Managing Director: Frank Mulcahy

Address: Roseville Business Park, Turvey Avenue, Donabate, Co. Dublin. Tel: (01) 808 5055 Fax: (01) 808 5150 Email: msheedy@portakabinallspace.ie Web: www.allspace.ie Business: Modular and portable buildings supply and manufacture. Contact: National Hire Manager: Mike Sheedy

particular sciences ltd Address: 2 Birch House, Rosemount Business Park, Ballycoolin Road, Dublin 11. Tel: (01) 820 5395 Fax: (01) 822 8813 Email: info@particular.ie Web: www.particular.ie Business: Scientific instruments, sales and support, material characterisation.

pilz ireland Address: Tel: Fax: Email: Web: Business: Contact:

Cork Business & Technology Park, Model Farm Road, Co. Cork. (021) 434 6535 (021) 480 4994 sales@pilz.ie www.pilz.ie Process and machinery safety engineering services and training. Sales Manager: Andrew Donnelly MD: John McAuliffe

PPD, Inc. Address: Tel: Fax: Email: Web: Business: Contact:

Building C, Athlone Business & Technology Park, Garrycastle, Athlone, Co. Westmeath. (0906) 460 300 (0906) 460 301 susan.neenan@ppdi.com www.ppdi.com Contract Research Organisation. Director, GMP Labs, Europe: Susan Neenan

Premier Validation Address: Tyone, Nenagh, Co. Tipperary. Tel: (01) 443 4016 Fax: (0906) 460 301 Email: graham.okeeffe@ premiervalidation.com Web: www.premiervalidation.com Business: Validation and regulatory compliance specialist. Contact: Director of Operations: Graham O’Keefe

Prime Pac Ltd PK CHEMICALS LTD Address: Tel: Fax: Email: Business: Contact:

Unit 23, Sandyford Office Park, Blackthorn Avenue, Sandyford Industrial Estate, Foxrock, Dublin 18. (01) 295 6977 (01) 295 8338 graeme@pkchemicals.com Chemical Distributor Technical Sales Manager: Graeme Locke

Address: Tel: Fax: Email: Web: Business: Contact:

Unit 2, Newpark Industrial Estate, Antrim, BT41 2DU. (0044) 2894 428 188 (0044) 2894 428 177 sales@primepacltd.com www.primepacltd.com Manufacturer & supplier of plastic containers. Director: John McGahon

49 63

COMPANY LISTINGS

ProSys Containment And Sampling Technology Address: Tel: Fax: Email: Web:

UIDA Business Park, Carrigtohill, Co. Cork. (021) 485 3900 (021) 485 3866 mmcl@prosys.ie www.prosys.ie

Q1 SCIENTIFIC Address: Tel: Email: Web: Business: Contact:

87 Westside Business Park, Co. Waterford. (051) 355977 info@q1scientific.com www.q1scientific.com Stability Storage (ICH/GMP) Louise Grubb, CEO

Quintiles Ireland Ltd Address: Tel: Fax: Web: Business: Contact:

Eastpoint Business Park, Fairview, Dublin 3. (01) 819 5100 (01) 809 9500 www.quintiles.com Clinical Research and Development. Managing Director: John Kiernan

Quitmann O’Neill Packaging Ltd Address: Tel: Fax: Email: Web: Business: Contact:

50 64

St. Brendan’s Road, Portumna, Co. Galway. (090) 974 1148 (090) 974 1459 sales@quitmannoneill.com www.qonpack.com Packaging Stockist & Distributors. David O’Neill, Shane McEnroy

SOLTEC (IRELAND) LTD

SARTORIUS MECHATRONICS UK LTD Address: Tel: Fax: Email: Web: Business: Contact:

Unit 41, The Business Centre, Stadium Business Park, Ballycoolin Road, Dublin 11. (01) 808 3050 (01) 808 9388 info.ireland@sartorius.com www.sartorius.com Laboratory & Process technology provider. Sales & service of laboratory & process weighing equipment. Nick Parsons

SCICHEM - CORK Address: Tel: Fax: Email: Web: Business: Contact:

Unit 14, Barryscourt Business Park, Carrigtwohill, Co. Cork. (021) 488 2388 (021) 488 2389 cork@scichem.com www.scichem.com Laboratory Suppliers. Branch Manager: John Molloy

SCICHEM – DUBLIN Address: Tel: Fax: Email: Web: Business: Contact:

Greenhills Industrial Estate, Walkinstown, Dublin 12. (01) 450 4077 (01) 450 4328 dublin@scichem.com www.scichem.com Laboratory Suppliers. Branch Manager: Seamus Amond

SMURFIT KAPPA IRELAND Address: Ballymount Road, Walkinstown, Dublin 12. Tel: (01) 409 0000 Fax: (01) 456 4506 Email: info@smurfitkappa.ie Web: www.smurfitkappa.ie www.skpackaging.ie Business: Packaging.

Address: Tel: Email: Web: Business: Contact:

Zone A, Mullingar Business Park, Mullingar, Co. Westmeath. (044) 933 5133 info@soltec.ie www.soltec.ie Soltec is Ireland’s only commercially operated solvent recycling plant. Solid hazardous waste collections also provided. Business Development Manager: Michael Corcoran

SOLV-ECHEM IRELAND LTD Address: Tel: Email: Web: Business: Contact:

Great Island Industrial Park, Ballincollig, Co. Cork. (021) 487 7066 tony@solvechem.com www.solvechem.com Chemical distribution, chemicals, solvents, water treatment, warehousing. Director: Tony Murray

Science foundation ireland (SFI) Address: Wilton Park House, Wilton Place, Dublin 2. Tel: (01) 607 3200 Fax: (01) 607 3201 Email: info@sfi.ie Web: www.sfi.ie Business: Government funding agency for research. Contact: Director - Strategy and Communications: Dr. Ruth Freeman

STERIPACK Address: Kilbeggan Road, Clara, Co. Offaly. Tel: (057) 933 1888 Fax: (057) 933 1887 Email: info@steripackgroup.com Web: www.steripackgroup.com Business: Contract Manufacturing Services, Medical And Pharmaceutical Packaging, Test Laboratory Services. Contact: Sales Manager: Colm Flood

Irish PharmaChem | Industry Buyers Guide 2016

COMPANY LISTINGS

SUSTAINABLE ENERGY AUTHORITY OF IRELAND Address: Glasnevin, Dublin 9. Tel: (01) 836 9080 Email: info@sei.ie Web: www.sei.ie Business: Energy advice & information.

THORNSHAW SCIENTIFIC RECRUITMENT Address: Tel: Email: Web: Business: Contact:

6 Old Dublin Road, Stillorgan, Co. Dublin. +353 1 278 4671 info@thornshaw.com www.thornshaw.com Scientific Recruitment Tina Dunne

SYNTHESIS AND SOLID STATE PHARMACEUTICAL CENTRE Address: University of Limerick, Limerick, Ireland. Tel: +353 (0)61 234629 Web: www.sspc.ie Business: Research Centre Contact: General Manager: Jon O’Halloran

TEDAC LTD Address: 31 Cleeve Lodge Road, Downend, Bristol, England, BS16 6AF. Tel: 004417 910 4821 Fax: 0044751 566 0775 Email: info@tedac.co.uk Web: www.tedac.co.uk Business: Temperature and humidity mapping services. Contact: Director: Chris Bell

teva pharmaceuticals ireland Address: Unit 301, IDA Industrial Park, Waterford. Tel: (051) 331 331 Web: www.teva.ie Business: Respiratory Pharmaceutical R&D and Manufacture. Contact: Managing Director: Andy Crowley

Irish PharmaChem | Industry Buyers Guide 2016

Toyota Material Handling Ireland Ltd Address: Tel: Fax: Business: Contact:

Killeen Road, Dublin 12. (01) 419 0200 (01) 419 0325 Forklift and Warehouse Supplies. Terry O’ Reilly

waters chromatography ireland Address: Unit 3.1 Woodford Business Park, Santry, Dublin 9. Tel: (01) 448 1500 Fax: (01) 448 1510 Email: ireland@waters.com Web: www.waters.com Business: The company designs, manufactures, sells and services HPLC, UPLC, mass spectrometry instrument systems and support products, including chemistry consumables and post-warranty service plans. Contact: National Sales Manager: Davnet Donnelly

Weber Packaging Solutions Ltd Univar Address: Tel: Email: Business: Contact:

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin. (01) 401 9800 pharma.sales@univar.com Chemical Distribution Key Account Manager: Niall Behan

Veolia Address: Tel: Fax: Email: Web: Business: Contact:

Address: Kilcannon Industrial Estate, Old Dublin Road, Enniscorthy, Co. Wexford. Tel: (053) 923 3778 Fax: (053) 923 3284 Email: sales@weberireland.com Web: www.webermarking.ie Contact: General Manager UK & Ireland: Patrick Hughes

Innovation House, DCU Innovation Campus, Old Finglas Road, Glasnevin, Dublin 11 +353 (0)1 870 1200 +353 (0)1 870 1201 info@veolia.ie www.veolia.ie Energy, Water and Waste management solutions Business Development Manager Pharma Sector: Sean Molloy

UK & Ireland: Patrick Hughes

wRENTECH LTD Address: Eversley, Church Bay Road, Crosshaven, Co. Cork. Tel: (021) 483 2644 Fax: (021) 483 1363 Email: smurray@wrentech.ie Web: www.wrentech.ie Contact: Sales Administrator: Siobhan Murray

49 65

Ye ar Pl a nne r 2 0 1 6 SUN MON TUE WED THU

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THU FRI SAT SUN MON TUE WED THU FRI SAT SUN MON TUE WED THU FRI SAT SUN MON

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Summer Time Begins

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27 28 29 30

A P R

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USEFUL REFERENCES ACADEMY OF CLINICAL

ELECTRICITY SUPPLY BOARD

INTERNATIONAL SOCIETY

IRISH PHARMACY UNION

SCIENCE AND LABORATORY

Tel: 1850 372 372

FOR PHARMACEUTICAL

Tel: (01) 493 6401

MEDICINE

E-mail: esbnetworks@esb.ie

ENGINERING (ISPE)

E-mail: firstname.surname@ipu.ie

Tel: (01) 905 9730

Web: www.esb.ie

Tel: +1 (813) 960 2105

Web: www.ipu.ie

E-mail: ask@ispe.org

E-mail: mail@acslm.ie Web: www.acslm.ie

ENTERPRISE IRELAND

Web: www.ispe.org

IRISH VENTURE CAPITAL

Tel: (01) 727 2000 ADVISORY COUNCIL FOR SCIENCE, TECHNOLOGY & INNOVATION

E-mail: client.service@enterprise-ireland.com Web: www.enterprise-ireland.com

E-mail: firstname.surname@djei.ie

ENVIRONMENTAL HEALTH

Web: www.sciencecouncil.ie

ASSOCIATION OF IRELAND Tel: (01) 276 1211

Tel: (01) 858 8100 LoCall: 1890 275 175 E-mail: bord@pleanala.ie Web: www.pleanala.ie

Tel: (01) 276 4647

ASSOCIATION

E-mail: secretary@ivca.ie

Tel: (01) 605 1584

Web: www.ivca.ie

E-mail: firstname.surname@ibec.ie

Tel: (01) 631 2858

AN BORD PLEANALA

ASSOCIATION IRISH BIOINDUSTRY

Web: www.ibec.ie/ibia

INVEST NORTHERN IRELAND Tel: (01) 234 2533

IRISH BUSINESS &

E-mail: dublin@investni.com

Web: www.ehai.ie

EMPLOYERS

Web: www.investni.com

ENVIRONMENTAL

Tel: (01) 605 1500

E-mail: info@ehoa.ie

PROTECTION AGENCY Tel: (053) 916 0600

CONFEDERATION (IBEC) MANDATE TRADE UNION

E-mail: info@ibec.ie

Tel: (01) 874 6321

Web: www.ibec.ie

E-mail: mandate@mandate.ie

LoCall: 1890 335 599

Web: www.mandate.ie

CHAMBERS IRELAND

E-mail: info@epa.ie

IRISH CLEANROOM SOCIETY

Tel: (01) 400 4300

Web: www.epa.ie

Tel: 087 958 8045 E-mail: info@cleanrooms-ireland.ie

E-mail: info@chambers.ie Web: www.chambers.ie

HEALTH AND SAFETY AUTHORITY

Web: www.cleanrooms-ireland.ie

Tel: (045) 880 400 COMPANIES REGISTRATION OFFICE Tel: (01) 804 5200 LoCall: 1890 220 226 E-mail: info@cro.ie Web: www.cro.ie

LoCall: 1890 200 857

BIOPROCESS ENGINEERING Tel: (01) 716 1825 E-mail: chemical.eng@ucd.ie Web: www.ucd.ie/chembioeng

DEPT. OF JOBS, ENTERPRISE & INNOVATION Tel: (01) 631 2121 LoCall: 1890 220 222 E-mail: info@djei.ie Web: www.djei.ie

FOR TRANSPORT & LOGISTICS (NITL) Tel: (01) 402 3000

IRISH COSMETICS,

E-mail: nitl@dit.ie

Web: www.hsa.ie

DETERGENT & ALLIED

Web: www.nitl.ie

HEALTH PRODUCTS

Tel: (01) 605 1671

E-mail: infoline@hsa.ie

REGULATORY AUTHORITY Tel: (01) 676 4971

PRODUCTS ASSOCIATION PARENTERAL DRUG

E-mail: siobhan.dean@ibec.ie

ASSOCIATION (PDA)

Web: www.icda.ie

Tel: +1 (301) 656 5900

E-mail: info@hpra.ie UCD SCHOOL OF CHEMICAL &

NATIONAL INSTITUTE

Web: www.hpra.ie HEALTH RESEARCH BOARD Tel: (01) 234 5000 E-mail: hrb@hrb.ie Web: www.hrb.ie HIGHER EDUCATION AUTHORITY Tel: (01) 231 7100 E-mail: info@hea.ie

E-mail: info@pda.org IRISH EXPORTERS

Web: www.pda.org

ASSOCIATION Tel: (01) 661 2182

PHARMACEUTICAL

E-mail: iea@irishexporters.ie

SOCIETY OF IRELAND

Web: www.irishexporters.ie

Tel: (01) 218 4000 E-mail: info@thepsi.ie

IRISH MEDICAL DEVICES ASSOCIATION Tel: (01) 605 1500 E-mail: imda@ibec.ie Web: www.imda.ie

Web: www.hea.ie

Web: www.thepsi.ie PHARMACHEMICAL IRELAND Tel: (01) 605 1584 E-mail: pharmachemicalireland@ibec.ie Web: www.pharmachemicalireland.ie

IRISH NATIONAL IDA - INDUSTRIAL

ACCREDITATION BOARD

REPAK

DEPT. OF THE

DEVELOPMENT AGENCY

Tel: (01) 614 7048

Tel: (01) 467 0190

ENVIRONMENT,

Tel: (01) 603 4000

E-mail: info@inab.ie

E-mail: info@repak.ie

COMMUNITY & LOCAL

E-mail: idaireland@ida.ie

Web: www.inab.ie

Web: www.repak.ie

GOVERNMENT

Web: www.idaireland.com IRISH PATENTS OFFICE

SCIENCE FOUNDATION IRELAND

LoCall: 1890 20 20 21

INSTITUTE OF CHEMISTRY OF IRELAND

Tel: (056) 772 0111

Tel: (01) 607 3200

E-mail: press-office@environ.ie

E-mail: info@instituteofchemistry.org

E-mail: patlib@patentsoffice.ie

E-mail: info@sfi.ie

Web: www.environ.ie

Web: www.instituteofchemistry.org

Web: www.patentsoffice.ie

Web: www.sfi.ie

Tel: (01) 888 2000

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