PharmaChem 2012

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201 2 examines what the FMD will mean for pharmaceutical manufacturers, wholesalers, brokers etc. . . . . . . . . . . . . . . 24

MINISTER’S FOREWORD Richard Bruton TD, Minister for Jobs, Enterprise and Innovation, outlines the challenges and opportunities facing the Irish Pharma/Life Sciences sector. . . 3 SECTOR OVERVIEW While there are undoubted challenges ahead for the industry, Ireland’s Pharmaceutical and Chemical sector is responding strategically, writes Matt Moran, Director of PharmaChemical Ireland . . . . . . . . . . . . . . . . . . . . . . . . 5 BIOTECHNOLOGY Michael Gillen, Director, Irish BioIndustry Association examines the European Commission’s Bioeconomy strategy and what it could mean for Biotechnology in Ireland. . . . . . . . . . 8 SCIENCE FOUNDATION IRELAND SFI has played an instrumental role in enhancing Ireland’s international reputation as a prominent force in the pharmaceutical arena. . . . . . . . . . . . . . . . . . . . 10 RECRUITMENT Ireland’s Pharmaceutical and Life Sciences sector can look to the future with confidence, according to Berkley Pharmaceutical & Life Sciences’ latest survey on job creation, employee morale and expansion. . . . . . . . . . . . . . . . . . 13 TAX CREDITS Ken Hardy, Partner, KPMG, explains the proposed changes to the R&D Tax Credit system and their implications for the PharmaChem sector. . . . . . . . . . 14 COVER STORY In today’s high pressure pharma and biopharma environment, out-

LIFE SCIENCES ENA Prosser, Fountain Healthcare Partners, examines the changing nature of Life Sciences in Ireland and calls for a coherent voice to represent the entire sector. . . . . . . . . . . . . . . . . . . . . . . . . 29 sourced and in-sourced laboratory testing resource solutions, such as those offered by Eurofins Lancaster Laboratories, can enable you with the tools to succeed. . . . . . . . . . . . . . . . 16 WASTE MANAGEMENT Indaver’s Total Waste Management service. . . . . . . . . . . . . . . . . . . . . . . . 19 INDUSTRY-ACADEMIC COLLABORATION The landmark Solid State Pharmaceuticals Cluster, a collaboration between five universities and ten pharma giants, points the way to the future for collaboration between industry and academia . . . . . . . . . . . . . . . 20 PREDICTIVE MAINTENANCE Understanding the role of Predictive Maintenance, and what Dalkia can offer your company in this regard. . 23 FALSIFIED MEDICINES DIRECTIVE We have two articles covering this hottest of topics. Ann McGee, Managing Director and Principal Consultant, McGee Pharma International, writes on maintaining compliance in transportation and distribution of pharmaceutical drug substances and product, while Dr Rebecca Cramp, Scientific and Regulatory Affairs Manager, IPHA,

published by: Tara Publishing Co. Ltd. 1/2 Poolbeg Street, Dublin 2. Tel: 241 3095 Fax: 241 3010 Email: kathleenbelton@tarapublishingco.com Managing Director: Fergus Farrell Director: Kathleen Belton Editorial: John Walshe Advertising Executive: Adrian Murphy Design and Origination by: Rooney Media, 73 Block A Rockbrook, Sandyford, Dublin 18 Printed by: W&G Baird

TRACEABILITY Zetes’ TotalProof solution ensures full traceability during the transportation of temperature-sensitive products . . . . . 32 LOGISTICS Johnston Logistics has evolved from a traditional domestic haulier to a true pan-European logistics provider. . . 34 PRODUCT IDENTIFICATION STANDARDS GS1 can help you to uniquely identify your products and comply with EU regulations, such as the Falsified Medicines Directive and UDI regulations . . . . . 36 INGREDIENTS Brenntag Pharma is a significant supply partner to the pharmaceutical sector . . . 38 CODE OF PRACTICE A guide to the revised IPHA Code of Marketing Practice for the pharmaceutical industry. . . . . . . . . . . . . . . . . . . 39

Listings Chemical Suppliers. . . . . . . . . .

General Suppliers . . . . . . . . . . .

Company Listings . . . . . . . . . . .

Useful References . . . . . . . . . . .

40 42 52 64

Irish Pharmachem 2012 gratefully acknowledges the assistance of PharmaChemical Ireland in the production of this publication.

Every effort has been made to ensure the accuracy of the information contained in this publication, but the publisher cannot accept responsibility for errors or omissions.

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30/05/2012 14:02

Minister’s Foreword

Facing the Future Richard Bruton TD, Minister for Jobs, Enterprise and Innovation, outlines the challenges and opportunities facing the Irish Pharma/Life Sciences sector for it to continue to be a major success story in the years to come.

A

s Minister for Jobs, Enterprise and Innovation, I am very pleased to provide this foreword for the 2012 PharmaChem Ireland Yearbook and Diary.

PharmaChemical Ireland’s vision is to position Ireland as a recognised centre of excellence for innovation and development in pharmaceutical, biopharmaceutical and chemical supply, thereby becoming the location of choice for the launch of new products. On the Government’s part, we will work with PharmaChemical Ireland and the wider sector to ensure that we maintain: • Strong local management and a solid reputation for industry-academia collaboration; • A 12.5% corporate tax rate and a 25% Research and Development (R&D) tax credit; • No stamp duty on Intellectual Property transfer in Ireland; • Leading edge industry infrastructure, with IDA Ireland linking companies with excellent pre planned sites, a developed sub-supply and world class design consultants.

We also have a thriving indigenous sector, which is highly innovative and dynamic. Indeed, Irish companies are competing successfully in international markets throughout the world. This sector has been growing at an average of 13% per annum over the last four years, with employment growing by 7% last year.

We have built up a very considerable base of research across the broad spectrum of higher education. There has been, and there will continue to be, simultaneous investment across disciplines to maintain this broad base of knowledge and capacity, and in specific strategic areas of national opportunity, in order to build on this base.

The Innovation Ecosystem All of this has served to support a comprehensive innovation ecosystem that is connecting research, teaching and enterprise support. It is imperative that such an ecosystem is designed to maximise the economic impact of research, thereby creating the innovators of the future and supporting new and existing industries.

Punching Above Its Weight Historically, Ireland has punched well above its weight in attracting some of the world’s leading pharmaceutical companies to establish operations here. We are also well recognised as a global hub for the Life Sciences sector.

IDA Ireland has played its part in ensuring we became the location of choice for these and other players in the industry. Our record is very impressive - it is clear that the pharmaceutical industry itself is one of major significance to the Irish economy: • Ireland is the world’s largest net exporter of pharmaceuticals, with exports valued at €55 billion.

• Nine of the top 10 Pharmaceutical and 15 of the top 25 Medical Technology companies have significant operations in Ireland.

• The industry contributes total tax receipts of €3 billion annually to the Irish economy.

• 44,000 people in 250+ enterprises are directly employed in Life Sciences in Ireland, with an equivalent number employed in service provision to the industry.

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M i nBi si ot et re ’csh nFo olro eg wyo r d

The Government appreciates the importance of continuing investment in Science, Technology and Innovation, including STEM (Science, Technology, Engineering and Mathematics) awareness activities.

In the current economic climate, with fewer resources available, it is the right time to prioritise our investment right across the board - this is also very much the case in the domain of research.

Priority Areas It is in this context that I recently welcomed the publication of the Report of the Research Prioritisation Steering Group. The Group was mandated to identify a number of priority areas and/or approaches to tackling national challenges/opportunities which should, on a priority basis, be underpinned by the future investment in publicly funded STI. The Group identified a number of priority areas which are of relevance to PharmaChem, including: • Connected Health and Independent Living; • Medical Devices; • Diagnostics; • Therapeutics – Synthesis, Formulation, Processing and Drug Delivery; • Manufacturing Competitiveness.

Following on from the publication of this Report, the Government announced the establishment of a Prioritisation Action Group, which will be chaired by my colleague, Sean Sherlock TD, Minister for Research and Innovation, which will oversee the implementation of the recommendations of the report.

Over the coming years, through investments in Innovation Fund Ireland, the State will partner with leading international VCs to provide liquidity to support the growth of world-leading high technology companies in Ireland. The biopharma industry is certainly one of the principal sectors that will benefit from this initiative.

• The need for greater engagement by the healthcare system with industry, particularly in relation to research, clinical trials and the development and related manufacturing of innovative healthcare products and services.

Meeting The Challenges Ahead The Government is committed to supporting the industry in meeting and overcoming these challenges. Our ‘Action Plan for Jobs’ has identified a number of key actions to be undertaken during 2012 in respect of the Health/Life Sciences sector. These include: • Delivering a Health Innovation Hub to drive collaboration between the health system and commercial enterprises, leading to the development and commercialisation of new healthcare technologies, products, services and start-ups emerging from within the health system and/or firms; • Enacting a Health Information Bill to support a conducive environment for health research in Ireland. This will streamline the ethics approval process for health research not governed by statutory regulation and EU law. The Bill will also provide a legal framework for the introduction of an individual patient identifier; • Supporting the development of Ireland as a Global Centre of Excellence for the Medical Device industry by providing a local high-quality, wide-scope, responsive CE mark certification service.

The Pharma/Life Sciences sector will continue to be a major success story for our country for years to come.

However, I do not take our past success for granted and I have no doubt that by working together we can succeed in building on our achievements to date and laying the foundations for the future success of the Pharma/Life Sciences sector in the Irish economy.

I wish PharmaChem Ireland every success in the year ahead.

Richard Bruton TD, Minister for Jobs, Enterprise and Innovation

The Challenges Ahead The Government is aware, as outlined in the Action Plan for Jobs, that while the Pharma industry has continued to grow, it does face considerable challenges: • Impending expiry of patents, global over-capacity, significant R&D costs and a low pipeline for new products in the pharmaceutical sector; • Downward pricing pressures from healthcare consumers, governments and insurers; • Increased pressures to demonstrate efficacy of new products and value for money.

Against this global backdrop, the sector in Ireland faces particular challenges: • Costs need to continue to decline, in particular labour waste and energy charges; • The skills gaps need to continue to be addressed; • We need to address the fragmentation in Ireland’s supporting infrastructures for clinical R&D and innovation; 4

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Sector Overview

PharmaChemical Ireland Strategy on Track While there are undoubted challenges ahead for the industry, Ireland’s Pharmaceutical and Chemical sector is responding to these challenges strategically, writes Matt Moran, Director of PharmaChemical Ireland.

R

ecent media coverage points to the penny having finally dropped with regard to the impending patent cliff. Though it may be news to the public at large, it comes as no surprise to the sector here in Ireland. My last two articles dealt in depth with the strategic response by the industry here to this challenge as driven by the members of PharmaChemical Ireland (PCI).

You will recall PCI have launched two strategy: documents to date. The first, ‘Innovation and Excellence: PharmaChemical Ireland Strategic Plan’, was launched in New York at DCAT in March 2010. This was followed by ‘Ireland: the Location of Choice for Scientific Investment’, launched in Washington DC last year.

PCI has established a standing committee on strategy and this committee continues to oversee the implementation phase. This committee brings together the industry, Government and its agencies and the research community.

Meanwhile, companies continue to drive down the cost of supply through smart application of lean manufacturing techniques. There are many examples of Irish sites significantly reducing their cost of goods via operational excellence.

The industry continues to attract investment in development and high end manufacture, including biopharmaceuticals, vindicating the strategy adopted

by PCI. In fact, if you total the recent announcements, it amounts to over well over €1 billion: see table below.

Embracing the Development Plus Manufacturing Model The industry continues to hold the view that the only way that the sector will meet the challenges presented by the patent cliff is to embrace the development plus manufacturing model, thereby expanding the mandate of existing companies in this country (see below).

The industry recognises the fact that it needs to work closely with the research community to assist in this process and also to uncover new opportunities for commercialisation of research. The industry also needs to try and access the health system to help the development of an effective clinical research base, resulting in translational research and the evolution of a clinical trials infrastructure.

Company

Investment In Euro

Type Of Investment

PFIZER PHARMACEUTICALS

200 Million

Biopharmaceutical

MSD IRELAND BALLYDINE

100 Million

Development Facility

ALLERGAN

330 Million

Biopharmaceutical

GENZYME/SANOFI AVENTIS

150 Million

Biopharmaceutical

AMGEN

150 Million

Biopharmaceutical

ELI LILLY

300 Million

Biopharmaceutical

MSD IRELAND BRINNY

29 Million

Biopharmaceutical

Over 600 new jobs will created as a result of this investment, sending a clear message that the sector remains committed to Ireland for the long term.

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Sector Overview

Transforming Ireland Through Innovation In keeping with the theme that the sector needs to innovate to stay competitive, PCI hosted their Third Biennial Conference in collaboration with The International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drugs Association (PDA), entitled ‘Transforming Ireland Through Innovation’.

A wide range of speakers explored in detail how the industry can apply innovation practically. High level speakers from the regulatory world, including Irish Medicines Board Chief Executive, Pat O’Mahony , as well as Christine Moore from the FDA, outlined how industry can embrace regulatory change to its advantage and to the benefit of the patient. The high level of compliance by the sector here remains a key strength and an ongoing reason why companies continue to invest in Ireland.

Common thematics were explored via key note addresses and focused workshops. Topics such as Operational Excellence, Quality by Design and Process Analytical Technology (PAT), Supply Chain and new business models were discussed in detail. There was an extensive range of speakers drawn from the industry, regulatory bodies and service providers from as far afield as India. This coming together of expertise underpinned the valuable critical mass of knowledge and experience that resides in this country, supporting a strong and vibrant Life Sciences sector

Message

to the Irish

Government

Finally, the Pharmaceutical sector is undergoing a sea change at the moment as major companies seek to stay in the market. An inevitable consequence of this has been a series of mergers and acquisitions, resulting in global overcapacity in the sector. Now more than ever, it is critical that Ireland sends a positive message to the industry.

Our healthcare policy supports access to innovative medicines and medical technologies that are developed in Ireland.

It is vital that Government continues to take a long term view of the overall cost of healthcare. Medical treatment funding is regarded as investment in the nation’s health and economic prosperity. Such an approach will send a positive signal to pharmaceutical companies. It is critical that Government policy is well aligned in this regard: if companies are being asked to support the sector by investing in innovation in manufacturing, they would expect the Irish citizen to be able to avail of these innovations in the marketplace.

In conclusion, it is fair to say that the sector here does face a range of challenges. However, it is also fair to say that the industry is well aware of these and that, through PharmaChemical Ireland, it is responding to these challenges strategically. All evidence points towards this strategy being firmly on track.

PharmaChemical Ireland recently hosted their Third Biennial Conference in collaboration with The International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drugs Association (PDA), entitled ‘Transforming Ireland Through Innovation’.

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30/05/2012 14:07

Biotechnology

Towards a Bioeconomy for Europe Michael Gillen, Director, Irish BioIndustry Association examines the European Commission’s Bioeconomy strategy and what it could mean for Biotechnology in Ireland.

T

he Strategy ‘Innovating for Sustainable Growth: a Bioeconomy for Europe’ adopted by the European Commission earlier this year offers a unique approach to address the challenges facing Europe in the coming decades.

With the world’s population approaching nine billion by 2050 and natural resources finite, Europe needs renewable biological resources for secure and healthy food and feed, as well as for materials, energy, and other products. In order to reduce the heavy dependency of its economy on fossil resources and mitigating climate change, Europe needs to move towards a post-petroleum society.

Research, Innovation & Skills

the bioeconomy’ and for biotechnology as an enabling technology. Each euro invested in EU-funded bioeconomy research and innovation is estimated to trigger €10 of value added in bioeconomy sectors by 2025.

Improving Synergies

Michael Gillen, Director, Irish BioIndustry Association and Senior Executive, PharmaChemical Ireland.

The Bioeconomy Strategy is based on three complementary pillars. The first pillar is focused on increasing investment into research, innovation and skills. Under the European Framework Programme for Research and

The second pillar of the Strategy aims to improve synergies and coherence between the priorities of the European research and innovation policy and other policies relevant to the bioeconomy. It will provide different platforms to enhance interactions between researchers, policy makers, industries and society and support similar initiatives in EU Member States and regions. The Strategy will also further develop international cooperation in the area of bioeconomy.

Expanding Markets In its third pillar, the Strategy provides support to new markets and the expansion of existing ones, for example by promoting the development of standards, sustainability assessments and labels for bio-based products to facilitate their uptake in consumer markets and by green procurement. It also promotes the establishment of networks of integrated and diversified biorefineries, demonstration and pilot plants across Europe.

Innovation ‘Horizon 2020’ (2014-2020), € 4.7 billion of funding has been proposed for bioeconomy research and innovation under the societal challenge, ‘Food security, sustainable agriculture, marine and maritime research, and 8

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Biotechnology

The Future for Healthcare Biotech in Europe EUROPE has the potential to be a world leader in biotechnology. Such is the message from ‘What Europe has to offer biotechnology companies: Unravelling the tax, financial and regulatory framework’, a joint report from Ernst & Young and EuropaBio, the European Association for Bioindustries.

The report notes how Europe holds many tax, financial and regulatory incentives for both established companies and start-ups, while the quality of the research base and the skilled labour force also serve to make Europe an attractive destination for biotechnology. However, the report argues that more needs to be done by industry and regulatory authorities alike, and the right policies and incentives for R&D development are essential to future growth.

In terms of healthcare biotechnology, 2012 is an important year for policy, according to the report, with both the Transparency Directive and the Public Procurement Directive going through legislative processes at European Parliament and Council levels, the conclusions and recommendations due from Vice President Tajani’s initiative on the ‘Process on Corporate Responsibility in the Field of Pharmaceuticals’ and the review of Clinical Trials legislation due this year.

In terms of the latter, the report insists that “a simplified and efficient regulatory framework for clinical trials is key to making Europe a more attractive place for clinical research”, allowing faster access to innovative treatments, while reducing the administrative burden and cutting costs for both public and private sector researchers.

The report goes on to note how another legislative debate, the revision of the directive on in vitro diagnostics, “should provide a timely platform to discuss the regulatory challenges for companion diagnostics, a critical element in personalised medicine”.

For more information on this report and its findings, see www.europabio.org.

A Science-Based Approach Finally, the Strategy promotes the development of sciencebased approaches to better inform consumers about product properties (e.g. environment sustainability) and to promote a healthy and sustainable lifestyle. The success of the Strategy, however, will very much depend on the engagement of Member States, regions, stakeholders in the research and innovation community, and citizens.

The Development

of

Biotechnology

in Ireland

In Ireland, biotechnology is largely rooted in the pharmaceutical business. Indeed over the last 10 years, we have seen a transition in the industry from one that traditionally made ‘small’ molecules, to one today where the three largest selling drugs in 2012 will be biopharmaceuticals.

“Each euro invested in EU-funded

bioeconomy research and innovation is estimated to trigger €10 of value added in bioeconomy sectors by 2025.”

Abbott Laboratories’ arthritis drug Humira will be the world’s top-selling medicine this year, with sales predicted to hit $9.3 billion, underlining the importance of biotech drugs, as revenue from old-style medicines drops, according to consensus projections compiled by Thomson Reuters Pharma. Humira also treats other inflammatory diseases and was recently approved in Europe to treat ulcerative colitis. Following Humira in second and third place, respectively, are two other biologic rheumatoid arthritis drugs: Remicade, by Johnson & Johnson and Merck & Co., and Enbrel, by Amgen and Pfizer.

The challenge for Ireland in the next 10 years is to develop the industry to such an extent that these drugs are not only manufactured here (both Remicade and Enbrel are manufactured in Ireland), but that the next generation of biopharmaceuticals are discovered here as well.

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Science Foundation Ireland

Research for Ireland’s Future Science Foundation Ireland has played an instrumental role in enhancing Ireland’s international reputation as a prominent force in the pharmaceutical arena. This has been achieved by strategically investing in research teams who generate new knowledge, leading-edge technologies and competitive enterprises in the fields of science and engineering.

E

stablished as the Government’s science agency in 2000, Science Foundation Ireland (SFI) has assisted the development of Ireland’s pharmaceutical credentials to a point where today, we are considered to be an emergent international hub for pharmaceuticals.

Since its establishment, SFI has invested over €1.575 billion in scientific research carried out over almost 3,250 awards. Across the broad Life Sciences sector, SFI has approved a total of 1,205, with a total value of €684m.

There are currently 385 active Life Science awards, with a value funded of €365m.

The importance and impact of the pharmaceutical sector in Ireland is both evident and appreciated across the public and private sectors. In March 2012, as part of its new Action Plan on Jobs, the Irish Government launched the Report of the Research Prioritisation Steering Group, which maps out the sectors into which State funding for scientific R&D will be channelled over the coming years.

Among the research areas identified as having the greatest potential for economic return are both Diagnostics and Therapeutics (synthesis formulation, processing and drug delivery). The Report highlights Ireland’s development of a significant research capacity in related areas such as biomedical research, nanotechnology, materials and photonics, and cites personalised medicine/companion diagnostics as among the main opportunities for commercialisation.

In relation to therapeutics, the Research Prioritisation Steering Group stresses the importance of pre-manufacturing research, responding to industry needs (for example, the manufacture and formulation of small molecules and bioprocessing research), while drug delivery is seen as a potential growth area, based on the development of innovative new systems.

At a structural level, the extension of SFI’s remit to incorporate applied research is being provided for by Government, and will further assist in exploring areas of

strategic opportunity for Ireland, among them pharmaceuticals.

The Commercial Viewpoint Commercially, Ireland is home to nine of the world’s top 10 global pharmaceutical corporations, while 11 of the world’s top 12 medical technology companies have a manufacturing base here. Ireland’s PharmaChemical industry generates over half of all Ireland’s exports and we are the largest net exporter of medicines in the world.

Ireland exports over €55 billion in pharmaceuticals annually and growth is notable in the biopharmaceutical segment of the industry, following the arrival in 2011 of Amgen and Biomarin in Dublin and Cork and the creation of a total of 400 new jobs at Eli Lilly in Kinsale and Allergan in Westport.

Academically, Ireland’s international ranking for the quality of its research remains impressive, and, in the last two years, we have consolidated our position within the top 20 countries for overall scientific performance.

Furthermore, with the trend of Ireland’s particular excellence in specific disciplines such as immunology continuing, our status in academia complements our commercial prowess and helps to convert excellent research into viable businesses and pharmaceutical products that generate employment opportunities, and of course health benefits.

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Science Foundation Ireland

Pharma-Related Investments Some of the most significant SFI pharma-related investments include: • The Alimentary Pharmabiotic Centre: this SFI Centre for Science, Engineering and Technology (CSET), based at UCC, is the flagship investment that has been made by SFI in gastroenterology. Their overall remit is to investigate the means by which intestinal bacteria influence health and disease and to this end, they work towards developing new therapies for lifelong debilitating gastrointestinal diseases, such as gastroenteritis, ulcerative colitis, and Crohns Disease. The APC has already seen the licensing of a probiotic treatment for Irritable Bowel Syndrome in the US through Procter and Gamble and has collaborations with multiple industry partners, including GSK.

• The Alimentary Glycosciences Research Cluster (AGRC) a strategic research Cluster (SRC) led by Professor Lokesh Joshi, SFI Stokes Professor, is based at NUIG and is a consortium of researchers from NUIG, UCD, Teagasc, NIBRT and UCC, in addition to a number of industry partners, tasked to explore the role of gut glycosylation in host-microbe interactions, including Agilent Technologies (HTP analytical Tech.), Alimentary Health (Probiotics and Pharmabiotics), Biomining inc. Biostatistical Analysis, Bristol MyersSquibb (BioPharmaceuticals).

• The Solid State Pharmaceutical Cluster (SSPC) led

by Kieran Hodnett at UL and with co-investigators located in UCC, NUIG, UCD and TCD, carries out associated research by finding methods to rationally design solid-state pharmaceutical materials in their required physical and chemical forms, through designing novel crystal synthesis and characterisation techniques and using theory and modelling to more clearly understand how best to produce tablets and other drug formulations (www.ul.ie/sspc).The SSPC has multiple successful industry partnerships with many of the world’s leading pharmaceutical companies, including Pfizer, Merck, GSK and Roche.

• The Molecular Therapeutics for Cancer Ireland Strategic Research Cluster is led by Professor John Crown. This cluster involves a consortium of scientists, including a number of clinical investigators, whose vision is to assemble and build a fully integrated national translational cancer drug discovery and development program for the benefit of cancer patients.

Their goal is to identify biomarkers and targets, identify new indications for molecular targeted agents, understand the molecular basis for sensitivity/insensitivity to molecularly-targeted agents (MTAs), and find ways to monitor therapy. The therapeutic areas encompass breast, melanoma, lung and prostate cancer. Industry partners include Roche, Anti-Cancer Inc, Novartis, Amgen, Caliper Life Sciences, Merck Sharp & Dohme, GlaxoSmithKline, Erigal, and Pfizer.

• The Irish Drug Delivery Network (IDDN) Strategic Research Cluster (SRC) is led by David Brayden at UCD, with four co-PLs based in UCC, TCD and the RCSI (http://www.ucd.ie/iddn). The main thrust of the IDDN’s research is to investigate novel ways of replacing injected medicines with drugs based on proteins and genes, which are administered either orally or through inhalation. The IDDN has forged a successful partnership with the indigenous enteric drug delivery company Sigmoid Pharmaceuticals and has other industry partners, including Genzyme.

• As part of SFI’s Technology Innovation Development Award (TIDA) programme for 2012, the following pharmaceutical-oriented projects received funding: - Prof. Rhodri Ceredig, NUI Galway (Title: Personalised stem cell therapy for inflammatory diseases: a feasibility study of whole blood testing for optimising patient specific stem cell potency and efficacy); - Dr Peter McLoughlin, Waterford IT (Title: Injectable device for the prolonged release of second-generation antihistamine drug); - Prof. John Findlay, NUI Maynooth (Title: A common therapeutic approach for both type 1 and type 2 diabetes); 11

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Science Foundation Ireland

SFI Centres for Science Engineering & Technology (CSETs) – Life Sciences Alimentary Pharmabiotic Centre (APC) at University College Cork (www.ucc.ie/research/apc) The goals of the APC include investigating the means by which intestinal bacteria influence health and disease; developing new therapies for debilitating gastrointestinal diseases (such as Gastroenteritis, C. Difficile, Ulcerative Colitis and Crohn’s Disease); exploring commercial opportunities in both the pharma and functional food sector; and positioning Ireland at the forefront of this exciting new area. Collaborating partners: Alimentary Health, GlaxoSmithKline and Teagasc (the Irish agriculture and food development authority).

Biomedical Diagnostics Institute (BDI), Dublin City University (www.bdi.ie) BDI is carrying out cutting-edge research to develop the next generation of biomedical devices that will directly affect the quality of people’s lives worldwide over the coming decades. The diagnostic devices and sensors will aim to detect minute concentrations of disease related molecules in biological samples like blood, saliva and breath. Collaborating Partners: ÅmicAB (recently acquired by J&J Ortho-Clinical Diagnostics), Analog Devices Inc., Becton Dickinson and Co., Biosurfit S.A, Enfer Technologies Ltd., Hospira Inc., Inverness Medical Innovations Inc., Millipore.

- Prof Terry Smith, NUI Galway (Title: Rapid molecular detection of pathogens from bio-pharmaceutical process water and sterile products).

The Future

for

Research

The 2012 capital allocation of €156m to SFI will ensure that the current cohort of 3,000 researchers (who collaborate with over 500 companies) and 28 large research centres are supported, as part of an overall cohesive plan to return Ireland to economic growth.

For more information about SFI-supported research and details of upcoming calls, go to www.sfi.ie.

Systems Biology Ireland, UniversityCollegeDublin (http://www.ucd.ie/sbi/) Systems Biology Ireland will build the foundations of the science through the development of platforms and expertise in systems biology by focusing on defined scientific projects. In an effort to solve critical biological and biomedical problems, SBI research projects will be driven by the need to address biological questions for tangible benefits. In order to achieve a systems level understanding, the conceptual framework to rationalise complex biological relationships will come from mathematical modelling. Collaborating Partners: NUI Galway and industry partners Hewlett Packard, Servier, Agilent Technologies, Siemens Ireland, Ark Therapeutics and Protagen AG.

SFI Strategic Research Clusters (SRCs) – Life Sciences • Reproductive Biology Research Cluster, Dr Alexander Evans UCD. • The Irish Drug Delivery Research Network (IDDN), Prof. David Brayden, UCD. • Network of Excellence for Functional Biomaterials (NFB), Prof. Abhay Pandit, NUIG. • Solid State Pharmaceuticals Cluster, Prof. Kieran Hodnett, UL. • Immunology Research Centre (IRC), Prof.

Kingston Mills, TCD. • Advanced Biomimetics for Solar Energy Conversion, Prof. James MacElroy, UCD. • Alimentary Glycoscience Research Cluster (AGRC), Prof. Lokesh Joshi, NUIG. • Irish Separation Science Cluster, Prof. Brett Paull, DCU. • Molecular Therapeutics for Cancer Ireland (MTCI), Prof. John Crown (DCU).

• Regenerative Medicine Institute (REMEDI), Prof Tim O’Brien, NUI Galway.

- Prof. Mauro F. A. Adamo, Royal College of Surgeons in Ireland (Title: Development of an organocatalytic enantioselective synthesis of secondary alcohols and its application to the synthesis of (S)-Duloxetine); - Dr. Adrienne Gorman, NUI Galway (Title: Host cell engineering approach to increase product titre in a mammalian cell expression system); 12

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Recruitment

Shoots of Recovery Shine Through Ireland’s Pharmaceutical and Life Sciences sector can look to the future with confidence, according to The Berkley Group’s latest survey on job creation, employee morale and expansion, writes Joanna Houston, EMEA Operations Manager, Berkley Pharmaceutical & Life Sciences, Engineering.

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reland enters 2012 on a wave of change and on the whole, most view this as a positive, the Pharmaceutical and Life Science sector being no different. We have experienced a phase of redundancy, redeployment and reorganisation and are now seeing shoots of progression shining through.

For the last eight years, Berkley has tracked market sentiment on job creation, employee morale and expansion across the market: this gives us a position of confidence in saying that most indicators in the recent Q1 2012 results would support positivity as we move through the year. More confidence is being demonstrated in Ireland than some of our European counterparts.

41% of our survey respondents are happy to state there will be more highly skilled job opportunities in the market here, a strong indicator to the sector. This sentiment is expanded further, with 22% confident of promotion and at least 43% expecting a pay rise throughout 2012.

Career progression and financial incentives have taken up the two top spots for reason to move job this year, while job security is in third place. This will be interesting to follow throughout 2012, if we see increased numbers of roles and higher job seeker expectations, perhaps we will see the recruitment strategies adopting more targeted approaches to secure the best hire, something for hiring managers to consider.

has also outperformed the other main European countries, including Italy (28%), Spain (17%) and even Switzerland (24%).

The Outlook By Skill Sector By skill, this time last year, many HR respondents in the Pharmaceutical and Life Sciences sector claimed the fields most likely to have changed based on downsizing activity, with the highest number of redundancies, were QA, Manufacturing and Capital Projects.

In 2012, we have good news for people employed in these skill bases: the number of QA, Compliance, Regulatory, Validation and Audit roles have seen a dramatic lift in Q1 of this year on both the permanent and contract marketplace. Sites are winning new products, new projects and are continuing to make global partnerships that give rise to a need for such skills. Manufacturing has seen a positive start to the year and more high-end and diverse operational roles have been created at the sites here to retain competitive edge internationally.

The European Viewpoint Ireland is still on the radar for international investment.

We take confidence from the major MNC’s here who are continuing to grow and invest, with Eli Lilly, Biomarin, Alkermes, Amgen and MSD, to name a few, expanding operations here. We are still attractive and in the last year, we have seen a serious rise in the number of virtual companies in our marketplace, while our talent pool is still at the cutting edge of pharmaceutical excellence.

Looking at our European rivals, Germany were the most optimistic out of any major economy in relation to job creation in the near future, with 62% of respondents believing that jobs will be created in the next six months. Respondents in the UK are much more pessimistic than those in Ireland, with just 24% of respondents predicting job creation. Ireland

About the Authors

BERKLEY Pharmaceutical and Life Science and Berkley Engineering continues to serve the sector in Europe and Asia with 10 international offices. The company is now present in the UK with a HQ in London. For more information, please contact their Dublin office +353 1 8724666 or Cork on +353 21 4289600.

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Tax Credits

Making R&D Tax Credits Work For Your Company Ken Hardy, Partner, KPMG, explains the proposed changes to the R&D Tax Credit system and their implications for the PharmaChem sector.

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he Government has recognised that investment in R&D should be given priority as one of the key drivers for long-term economic growth. Finance Bill 2012, published on February 9, set out further details of the improvements proposed to the R&D tax credit scheme, which are aimed at encouraging increased investment by both multinational corporations and small and medium enterprises (SMEs) in R&D activities.

Overview

of

Qualifying activities encompass activities carried out by companies in a very broad range of industries. In the PharmaChem sector, qualifying activities could include the following: API development • Development of improved containment procedures for potent APIs; • Development of new or improved processes for solvent recovery and recycling; • Optimisation of existing chemistry synthetic routes and processes; • Implementation of the use of lean tools to streamline the API production process; • Development of new chemometric modelling approaches to ensure that potency predictions are accurate.

Existing Credit Regime

The tax credit is available to companies, within the charge to Irish tax, that undertake R&D activities in the EEA. A 25% credit is available for incremental qualifying expenditure over the amount spent in the base year (currently 2003) on qualifying activities. For example, a company spending €1,000 on R&D could potentially claim up to €250.

Qualifying expenditure can include direct expenditure, e.g. salaries and consumables; indirect expenditure, e.g. allocation of rent and rates, light and heat; and the expenditure incurred on plant and machinery to be used for the purposes of R&D activities. Currently, the R&D tax credit can be offset against the corporation tax liability of the company with any excess refundable to the company over a three-year period (subject to certain conditions).

Finance Bill 2012 The proposed changes to the R&D tax credit regime announced in Finance Bill 2012 include the following: 1. Employee Reward Mechanism This is a new reward mechanism for key employees who have been actively involved in the R&D activities of a company. It will allow them to effectively receive part of their remuneration tax free.

The key features of this mechanism are as follows: • The employee cannot be a director of the company or have a material interest in the company or be connected to such a person.

• The employee must perform at least 75% of their activities “in the conception or creation of new knowledge, products, processes, methods and systems” and at least 75% of the emoluments of the employee must qualify for the R&D tax credit.

• The amount of credit that can be surrendered to key employees is capped at the amount of corporation tax due by the company before taking the R&D tax credit into account, i.e. the company must be tax-paying. The employee’s effective tax rate cannot be reduced below 23%.

By virtue of the fact that a company has to be taxpaying to avail of the reward mechanism, and that the key employees cannot be directors or have a material interest 14

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Tax Credits

6. EU Grants While the legislation previously specified that expenditure met by grant assistance from the State would not qualify for the credit, this has now been extended to include grants or other assistance received from the EU or European Economic Area.

in the company, this measure as currently drafted is likely to have greater relevance for multinationals rather than SMEs. The example below illustrates how this will work in practice:

Summary The Finance Bill has proposed a number of amendments to the R&D tax credit that appear aligned to Government strategy by increasing investment in R&D activities in Ireland.

The introduction of a volume-based regime and the changes in the outsourcing limits certainly increase the attractiveness of the regime to SMEs and will allow such companies to claim increased credits, which are likely to be reinvested in the business.

The new employee reward mechanism, however, is unlikely to assist SMEs in attracting and retaining key R&D personnel and appears to be aimed primarily at multinationals. It would be preferable that, for SMEs, the director/material interest criteria be removed, in addition to the requirement that the amount available for surrender be restricted to the corporation tax liability of the employer company.

To find out how the changes to the R&D tax credit regime affect you, please contact Ken Hardy in KPMG’s R&D Incentives Practice on 01 410 1645, or email ken.hardy@kpmg.ie.

2. Introduction of a Volume-Based Regime The Finance Bill has introduced a volumebased regime whereby the first €100,000 of group expenditure is excluded from the incremental basis of calculation. Companies claiming the R&D tax credit will, therefore, have up to €25,000 of additional tax credits per annum (effectively cash) available to reinvest. This change will therefore be particularly valuable to SMEs. 3. Changes to the Existing Subcontracting Rules The existing subcontracting rules have been changed, whereby a company can now claim an R&D tax credit for subcontracted spend, based on the greater of the current percentage-based limits (subcontracted R&D expenditure paid to unconnected third parties/third level institutions restricted to 10%/5% of the company’s in-house spend) or €100,000. However, the total amount claimed cannot exceed the qualifying expenditure incurred by a company itself in the period.

SMEs tend to outsource a greater proportion of their activities as they would not have all of the necessary inhouse capabilities required for their R&D activities. This increase in the outsourced cap will therefore increase the R&D tax credit that can be claimed by SMEs, which is likely to be subsequently reinvested in the business.

About the Author:

KEN Hardy leads KPMG’s R&D Incentives Practice, and has prepared a large number of substantial R&D Tax Credit claims for multinational corporations, as well as for small and medium-sized enterprises. He also has significant experience of R&D Tax Credit audits conducted by Revenue.

Ken is a founding member of KPMG’s Global R&D Incentives Leadership team. He also leads their Tax Depreciation practice, where he advises corporate and individual clients with Irish and international property interests on capital allowances issues.

4. Management and Control of R&D Activities Expenditure incurred in the managing or control of R&D activities will not qualify for the R&D tax credit unless R&D activities are carried out by the company itself.

5. Transfer of a Trade – Carried Forward Credits & Buildings R&D tax credits carried forward can now be transferred intra-group as part of the transfer of a trade (subject to certain conditions). R&D tax credits can also continue to be claimed on buildings qualifying for the R&D tax credit following a transfer of that building as part of a trade (again subject to certain conditions).

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Cover Story

Sourcing the Right Solution In today’s high pressure pharma and biopharma environment, out-sourced and in-sourced laboratory testing resource solutions, such as those offered by Eurofins Lancaster Laboratories, can enable you with the tools to succeed.

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he global biopharmaceutical development and commercial supply chain model is changing. Market forces are causing management to challenge current corporate infrastructure to remove fixed costs and enable greater flexibility and responsiveness. This is impacting the development and commercialisation of new products and also the supply of marketed products to global markets. Mergers and resultant consolidation have only delivered some of the intended cost savings, and global biopharma has been forced to rationalise further in many areas. To further compound these challenges, the generic and biosimilar producers are becoming ever more adept at taking market share quickly.

For the research-based biopharma companies, demands from the regulators for compelling efficacy and safety data from new product candidates have led to numerous failures in clinical development. Clinical functions have increased internal scrutiny on their pipelines and greater selectivity is being practiced to avoid the cost of fruitless development efforts.

Many large organisations have gone from a scattergun approach, where multiple development candidates were progressed into late phase to ensure a small number got through, to only developing those with the highest chances of success. Licensing and partnering are high on corporate agendas to address immediate candidate shortages. This has its own effect on development functions, where development candidates are shoe-horned into the CMC development process, and these technologies are often departures from organically developed candidates, exposing both resource and expertise gaps within new leaner organisations.

Blurring

the

Eurofins Lancaster Laboratories has developed models which enable a rapid response to changing demands, while retaining client-specific knowledge of projects and preferred ways of working.

This is a high potential but more unpredictable strategy.

Products can fail: market approval does not guarantee immediate success. Scrutiny of individual member states in Europe shows that take-up of new products is slower, with manufacturing campaigns more sporadic.

In the laboratory environment, these factors create opposing objectives. On one hand, biopharma needs rapid access to a wide range of expertise and resources, while on the other, they seek to reduce internal headcount and associated fixed costs.

Through increased out-sourcing of analytical activities, Eurofins Lancaster Laboratories has developed outsourcing models which enable a rapid response to changing demands, while retaining client-specific knowledge of projects and preferred ways of working.

Lines

Where product development ends and commercialisation and post-marketing manufacturing operations begin have become blurred. Facilities in western Europe are vying with their low cost, emerging market affiliates and are positioning themselves higher up the value chain, leveraging their experience to support the introduction of late phase clinical and newly approved products to the global supply chain.

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Cover Story

Full Time Equivalents The Full Time Equivalent Models (FTE) is based on dedicated testing personnel, who work exclusively for one client. It is most effectively deployed when there is an ongoing need that may increase or decrease in resource demand over time. Typically, analysts are utilised on a monthly basis. A core team operates continuously, with additions accessed when demand spikes. Another significant advantage to this approach is the simplified commercial interaction between the client and laboratory: task specific quotations, purchase orders and invoices are no longer required.

Resources are purchased on a ‘per headcount, per month’ basis, reducing greatly this administration. The client still retains the ability to increase or decrease the resource over time, providing a truly variable cost resource.

A global head of Analytical Development recently discussed this challenge at a business review: “No matter how much we put the effort into defining processes for out-sourcing discreet packages of work to our contract service partners, we always experience inertia at the outset of a new project. Developing project-specific contracts, educating the organisation on our needs and the interaction process to achieve technical transfer always took longer and more resources than we wanted or planned for.

Embedding a core team that can service our ongoing needs and the ability to flex the size of the team over relatively short time-frames creates a seamless arrangement between our technical leads and the analytical resources. Once established, the team is familiar with our requirements and can respond quickly, often anticipating our needs.”

The FTE approach can be deployed in a number of different scenarios: typically development testing QC or CMC functions utilise it to accommodate gradually fluctuating resource requirements. In the commercial arena, it is often used to provide a cost-effective solution for transitional projects like process development or new product introductions, when the overall scope requires access to

Using the FTE model, resources are purchased on a ‘per headcount, per month’ basis.

specialist expertise over a mid-term horizon. The graphic below shows how FTE ramped up and down over 14 months to support a new solid oral dose product introduction at a manufacturing facility in Ireland.

Method Development and Validation

Process Development Support

Stability Set Down

Professional Scientific Staffing Professional Scientific Staffing (PSS) is an award-winning, in-sourced scientific staffing solution, where Eurofins Lancaster Laboratories utilises its combined scientific and HR best practices to recruit, train and manage testing teams in clients’ facilities to undertake specific activities using the clients’ quality systems. This model has evolved and extended to meet varying needs of the industry, including discovery, pre-clinical and clinical support, process development, and GMP laboratory services in a variety of scientific disciplines.

Typically a number of drivers lead clients to this solution: • They have permanent headcount restrictions; • Traditional temporary contract workers are not delivering the expertise, productivity and consistency in tenure for the needs of the operation;

The Full Time Equivalent Models (FTE) is based on dedicated testing personnel, who work exclusively for one client.

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Cover Story

• Temporary employment legislation is creating commercial and compliance issues for the client operations; • They require the activities to be conducted within their facilities, IT and quality systems.

“PSS was partly invented by our customers,” explains Beth DiPaolo, Global VP of PSS. “Our relationships began with traditional out-sourced services, but discussions began to take us to a more in-sourced solution to meet their needs. They had specific technical leadership expertise. They needed a flexible resource but were looking at rapid expansion of their development and QC GMP lab operations. PSS evolved to provide staffing solutions and has expended across the industry. Now we have more than 500 staff deployed across approximately 30 client locations in the US and Europe.”

Taking Over Routine Operational Functions Organisations often use PSS to take over routine ringfenced operational functions, such as EM and QC testing.

As a high throughput GMP testing operation, Eurofins Lancaster Laboratories’ PSS has a decade of experience in optimising sample throughput through establishing continual improvement initiatives with the client’s lab, achieving improved productivity and ultimately cost reduction.

PSS can also be used to augment functional testing teams within the overall laboratory structure, when demands move from area to area over time. Cross-training enables staff to move within functions easily, giving greater inherent flexibility to support headcount demands as they arise across the wider organisation.

All PSS Teams have an on-site leader, who is responsible for providing technical contributions, team oversight, client satisfaction, and ensuring all quality and productivity metrics are met. This provides effective point of communication with on-site client management for planning purposes and ensures performance of the group is effectively managed. It also ensure compliance with the Temporary Workers Directive, in that the management of resources is orchestrated by Eurofins Lancaster Laboratories, so clients are freed up to focus on their priorities. All PSS staff are full-time Eurofins Lancaster Laboratories personnel, outside of the client’s reporting framework. Employees receive all the benefits of Eurofins Lancaster Laboratories full-time positions.

Professional Scientific Staffing (PSS) is an award-winning, in-sourced scientific staffing solution, where Eurofins Lancaster Laboratories utilises its combined scientific and HR best practices to recruit, train and manage testing teams in clients’ facilities to undertake specific activities using the clients’ quality systems.

ties are in place. The implications of working outside the organisational LIMs and quality systems can be too significant, with quality and compliance at the top of the client’s agenda. For this client, PSS proved the perfect solution.”

Success was dependent on delivering the elements of the project: • Appropriate recruitment and skill sets; • Cleary defined scope of work and operating procedures; • Effective and fast induction and training; • Ongoing management within a continual improvement framework.

Both FTE and PSS models provide solutions to manage laboratory testing activities effectively. Both scenarios allow access to Lancaster Labs’ technical expertise and experience through variable cost frameworks. The right solution depends on the client scenario and their operational and risk assessment approach. Increasingly, organisations use these models in combination, thereby achieving maximum flexibility.

A PSS Case Study “We recently met with a major UK-based pharmaceutical client,” notes Beth DiPaolo. “The discussion followed an increasingly familiar path. Their needs were diverse: focusing fixed internal headcount on high value technical projects, while achieving high efficiency in the more routine microbiology QC laboratory, with the ability to flex to variable demand. Sometimes, activities are not able to be remotely out-sourced, as capital equipment and facili-

For either in-sourced or out-sourced resource solutions, contact Mark Glass, Business Development Director at Eurofins Lancaster Laboratories by email: mglass@Lancasterlabs.com.

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Waste Management

Indaver: Total Waste Management Partner for Pharma Industry

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ndaver’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.

With over 30 years’ experience, Indaver has the expertise to provide sustainable, cost effective and tailored 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 facilities in Ireland include the EPA licensed Dublin Port Hazardous Waste Facility, incorporating a transfer station, a laboratory and a state-of-theart solvent recovery facility. For nonhazardous waste, Indaver has constructed Ireland’s first Waste-to-Energy facility in Duleek, Co. Meath. The €140m facility has been operating since August 2011, and is helping Ireland meet its EU and national objectives by diverting 200,000 tonnes of municipal solid waste away from landfill and up the waste hierarchy to recovery every year. The company is currently seeking an amendment to the waste licence, which would allow this local facility to treat a broader range of waste streams.

Pharma Waste Experts Indaver offers a full range of services for the management of pharma waste: ■ Waste-to-Energy – a real alternative to landfill ■ Fully accredited waste operators ■ Solvent Recovery ■ Lab Smalls classification & disposal ■ Activated Carbon info@indaver.ie Tel. +353 1 280 4534 ISO

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Leading the field in Sustainable Waste Management

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30/05/2012 14:18

I n d u s t r y -A c a d e m i c C o l l a b o r a t i o n

SSPC’s Partnership Approach Works The landmark Solid State Pharmaceuticals Cluster, a collaboration between five universities and ten pharma giants, points the way to the future for collaboration between industry and academia.

A

s one of the world’s most highly regulated industries, the pharmaceutical sector has significant and costly problems with the lack of reproducibility of solid-state forms. Costs increase when material must be reprocessed or discarded because a product is outside of its regulated specification, due to failure of a unit operation. The lack of a fundamental scientific understanding of phenomena such as crystallisation, phase transformations, polymorphism, mechanism of desolvation and physical forces involved in precipitation, drying, milling and compression lie at the heart of these problems.

Professor Kieran Hobnett, Scientific Director and Lead PI, SSPC, University of Limerick.

The Solid State Pharmaceuticals Cluster (SSPC), led by Professor Kieran Hodnett at University of Roche, Merck Sharpe & Dohme, Bristol Meyers Squibb, Limerick, with co-investigators located in UCC, NUIG, Clarochem Ireland, UCB Pharma and Schering Plough.

UCD and TCD, provides the necessary skill-set to comprehensively investigate pharmaceutical solids by bringing Uniting Academic & Industry Strengths together complementary academic and industrial groupings from the disciplines of Chemistry, Pharmaceutics, While in the past, it has traditionally proved difficult to Pharmaceutical Technology, Chemical Engineering and engage pharmaceutical companies in multi-company initiaMechanical Engineering. These groups have expertise tives, for a number of reasons, including the perceived risks in process modelling and design, scale-up, computational to intellectual property etc, the SSPC has already proved a fluid dynamics, in situ solution and solid-phase monitoring, fantastic success and is seen as something of a benchmark crystallography and powder characterisation. for future collaboration between academia and industry.

In essence, the SSPC is designed to link scientists and “The collaboration across academia and the engineers in partnerships across academia and industry to Pharmaceutical industry through the cluster mechanism address crucial research questions. is unique globally and is certainly recognised in Pfizer It carries out associated research by finding methods Ireland manufacturing as a real advantage,” said Dr Liam to rationally design solid-state pharmaceutical materials Tully, Director of Pfizer’s Global Process Development in their required physical and chemical forms, through Centre, located in Cork. designing novel crystal synthesis and characterisation The Cluster unites academic strengths, such as research techniques and using theory and modelling to more clearly experience, analytical techniques & equipment, with indusunderstand how best to produce tablets and other drug try’s fortes, namely: plant experience, process knowledge, formulations. process & pilot plant equipment.

The Academic institutes involved include: University of “In GSK, we consider it really important for our scienLimerick; University College Cork; National University of tists to have close interactions with academia to ensure we Ireland, Galway; University College Dublin; and Trinity are using the best available science and technology in the College Dublin. The pharmaceutical companies include development and manufacture of our processes,” noted Dr some of the biggest names in the industry, like Pfizer, Siobhan Creedon, Technical Director, GSK Cork. “It is GlaxoSmithKline, Eli-Lilly, Janssen Pharmaceuticals, critical for us as a new product introduction site to have a 20

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good understanding of the core unit operations of crystallisation, filtration, drying and milling. These operations are critical to facilitate technology transfer and scale-up, which are fundamental to the successful and rapid introduction of new products. The SSPC provides a unique forum for our scientists to have regular and close interaction with our industry and academic colleagues throughout Ireland.”

– Population balance and Particle Size – Analytical methods for solids The SSPC also saw the establishment of a Best Practice Crystallisation Focus Group, which identifies and describes current best practice in crystallisation and crystallisation-related unit operations. This is unique in the fact that potential competitors are working together for a common goal, and is the first ever searchable resource, combining industry and literature best practice, allowing for informed choice-making for those involved in, or newcomers to, the field of crystallisation.

SSPC Objectives The SSPC is not just a good idea in theory: it also has a number of concrete objectives, including: • Generic crystallisation training; • Bespoke training in niche areas; • Access to equipment and expertise; • Consultancy engagement activities - engaging industry in preliminary discussions on potential research projects; • Best Practice collaboration; • Student placement programmes; • Quarterly Technical meetings: mix of academic and applied topics; • Company specific projects – shared IP of generic learning; • Platform projects – multi company; • Continued education certification programme; • Joint publications; • Increased collaboration with like-minded clusters internationally; • The establishment of a new network of academic and industrial partners; • Potential commercialisation of research.

Research Projects The SSPC’s biggest benefit, however, is sure to be its research activities. These industrially relevant research projects are selected around three working research strands: 1. Process Crystallisation Historically, the trend in industry has been in batch crystallisation. In more recent times, there has been a movement, industry-wide, to look at continuous crystallisation. This strand assesses both and attempts to predict which is the more suitable for any given case.

Scale-up from kilo lab to pilot to plant is addressed and use of modelling tools to optimise process yield, particle size and quality attributes are researched.

2. Particle Engineering This strand looks at developing the capability to ‘tailor-make’ the attributes of the active ingredient to suit downstream activities. Getting the correct particle size shape and polymorphic form will lead to less batch failures, elimination of unit operations such as milling and a more consistent input to the formulation process.

The SSPC Training Programme was created for both students and industry cluster members to increases the knowledge levels across the industry. Modules include: – Crystallisation Fundamentals – Aspects of Preformualtion – Polymorphs and Solvates

3. API-Formulation Interface Here, the researchers challenge the communication gap between the API producer and the formulator. The attributes of the API and indeed excipient that dictate formulation behaviour are studied. Such attributes may not even be included on current material analysis sheets. Difficult to ascertain characteristics such as ‘flow’, as well as the traditionally tested parameters, may well hold the clue to solving formulation difficulties all too frequently experienced in industry.

From Strand 1, the Continuous Crystallisation Platform project (CCP) has also delivered, having already achieved a number of targets: five day continuous steady state operation; the application of cooling and antisolvent crystallisation systems; the processing of six generic materials: benzoic acid, glutamic acid, mannitol, p-amino benzoic acid, paracetamol and acetaminophen; Slurry transfer technique developed; Kinetic and modelling evaluation protocols under development; DynoChem model construc-

The SSPC provides the necessary skill-set to comprehensively investigate pharmaceutical solids by bringing together complementary academic and industrial groupings from a range of disciplines.

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academia can bring in the area of crystallisation and now wants to use the SSPC model of inclusivity and equity of resources to look upstream at areas of process chemistry and catalysis and further downstream in the area of drug product formulation to help demonstrate the value of doing business in Ireland to corporate Pharma globally. Plans for the next incarnation of the SSPC are well advanced, with the prospect that this will be in place in 2013.

“The SSPC has been profiled internationally as an example of a best in class industry-academic collaboration,” explains Jon O’Halloran, SSPC Manager, University of Limerick. “This is mainly due to its research profile, which is relevant to the challenges facing the pharmaceutical industry. Participation in SSPC initiatives like the members only Best Practice web portal bpx.ie and ATTLAS demonstrate that Ireland can not only perform competitively but can offer benefits back to global HQs.”

The SSPC unites academic strengths, such as research experience, analytical techniques & equipment, with industry’s fortes, namely: plant experience, process knowledge, process & pilot plant equipment.

Conclusion The Pharmaceutical sector in Ireland has a pressing need for more expertise to deliver on its own strategies of moving the business here more up the value chain. Maintaining this industry that delivers 50% of Ireland’s exports is critical for the Irish economy. Industry-academic collaboration in this space is critical to ensure this happens. The continued success of the SSPC is a shining light, both for the future of crystallisation and industry-academic collaboration in Ireland.

“Pharmaceutical companies in Ireland have a long history of sharing pre-competitive information through involvement in the working groups facilitated by the PharmaChemical Ireland wing of IBEC,” concludes Michael Napier, Scientific Fellow, Janssen Global Technical Services. “The establishment of a single strong academic grouping in Ireland allied to the pharmaceutical collaboration in this area adds considerably to the general technical knowledge base in Ireland. The journey so far has definitely been a case of a rising tide lifting all boats. We still can look forward to waves of progress.”

tion underway. UCD and UL have identified modelling and experimental collaborations to enhance continuous technology development.

Service Dominant Logic Approach The SSPC is more than just a research centre however.

It employs a service dominant logic approach to its dealings with industry and academia alike. Taking advantage of the community of practice that is the SSPC, it listens to the needs of its partners and tries to add value over and above pure research activities. In the last year alone, the SSPC has further engaged with industry, with Cluster PhD students being placed in several pharmaceutical companies throughout Ireland, while one of the SSPC’s biggest projects has been the development of ATTLAS (Access to Third Level Analytical Services), a web portal created by the SSPC that consolidates the expertise in analysis in the Irish HEI sector and has functionality that makes it easy to access by industry: www.attlas.ie.

Recognising that the Pharma industry in Ireland sends a significant volume of business overseas to contract research organisations to carry out specific analysis, services which could potentially be channelled to the Higher Education Institutions (HEIs) in Ireland, the SSPC created ATTLAS. The site covers a range of categories, including chemical analysis, chromatography, electrophoresis, nucleic acid analysis and spectrometry. It is expected that through increased engagement on service facilitated by ATTLAS that this will result in enhanced research collaboration between academia and industry.

CGOM10

THE 10th International Workshop on Crystal Growth of Organic Materials is to be held at the University of Limerick from June 11-14, 2012.

It is organised by the SSPC, in collaboration with international partners in UK and France.

Speakers include Prof. Roger Davey, University of Manchester, Prof. Chick Wilson, University of Bath, Dr Lynne Taylor, Purdue University, Indiana, and Dr Rolf Hilfiker, from Solvias, Switzerland. The CGOM meeting series, established in the early 1980s, is dedicated to the interplay between physico-chemistry, crystallisation kinetics and the solid form product properties of organic crystals. See www.cgom2012.com for more information.

The Future Recognising that standing still is not an option, the SSPC is now looking to extend its remit beyond the area of crystallisation. The Pharma industry has seen the benefits that 22

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PREDICTIVE MAINTENANCE

UNDERSTANDING THE ROLE OF PREDICTIVE MAINTENANCE

P

harmaceutical production is one of the world’s most heavily regulated industries. With such an emphasis on product quality within the industry and with such economic and health consequences due to machine failure, the maintenance team plays a crucial role in the success of the product. The maintenance department must ensure equipment is kept to its maximum operating condition. It must predict and prevent failures and repair any problems which may already have led to a failure, while adhering to the rules and procedures set out by the respective regulatory bodies.

The use of Predictive Maintenance or Condition Based Maintenance has dramatically reduced non-value added maintenance by eliminating the need to unnecessarily shutdown equipment for maintenance checks. Some of the main technologies currently used in industry are: - Thermography: infra-red imaging to detect abnormal temperatures or hot spots; - Vibration monitoring: accelerometer instruments can be used to detect abnormal or high vibration, particularly in bearings;

-

-

Oil analysis: sampling of oil (which is then analysed) can detect the deterioration or breaking down of an internal equipment part; Ultrasonic measurement: use of ultrasound technologies to detect leaks or blockages on utilities systems.

WORTHWHILE INVESTMENT Predictive Maintenance is a widely accepted approach to the maintenance strategy for both GMP and non-GMP utilities equipment. Any facility with utility systems should employ some methods of Predictive Maintenance. Initial investment is negligible as Predictive Maintenance programs have been shown to pay for themselves many times over.

To discover how Dalkia can assist you in this regard, please contact info@dalkia.ie or visit their website at www.dalkia.ie. Dalkia enables its customers to achieve operational improvement and financial efficiencies, as well as a reduction of their carbon footprint.

Creating Energy Progress To meet environmental challenges and cost and quality-of-care objectives, Dalkia creates imaginative energy solutions for you.

By partnering with a leading comprehensive utilities management specialist, you share a sustainable approach to the development of your site and the most innovative optimization solutions in all safety.

Services for Pharmaceutical industries: Energy & Environmental Solutions Utilities Services Compliance, Risk-based and Lean Approach Multi-technical Asset Management Services Asset Life Cycle Management

Contact: Colm Flanagan Commercial Director, Dalkia 145 Lakeview Drive, Airside Business Park Swords, Co. Dublin Tel: 01 870 1200 Email: info@dalkia.ie

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Falsified Medicines Directive

What the FMD Means For You Ann McGee, Managing Director and Principal Consultant, McGee Pharma International, writes on maintaining compliance in transportation and distribution of pharmaceutical drug substances and product, with the adoption of the Falsified Medicines Directive.

F

ollowing an increase in falsified medicines detected within the EU in recent times, the Falsified Medicines Directive (FMD) 2011/62/ EU has been adopted at EU level to tighten the control of distribution chains for medicinal products. The FMD introduces strengthened requirements for EU and non-EU manufacturers of active substances, as well as for wholesale distributors of medicinal products.

The EU’s Falsified Medicines Directive forms part of the Pharma Package, a series of measures proposed by the European Commission in December 2008. The Directive aims to prevent falsified medicines from reaching the patients by introducing harmonised, pan-European safety and control measures. These measures will ensure easier identification of falsified medicines, and improved verifications and controls at EU borders and within the EU.

What

are

Others include stronger requirements for the control and inspection of EU plants manufacturing APIs, improved scrutiny of brokers and traders, and sanctions against counterfeiters and obligations to report suspicions of falsified medicines. The directive was published in July 2011 and will come into force in 2013. However, not all measures proposed in the directive will come into force at the same time. They will be introduced by a series of delegated acts. This is the new regulatory procedure for amending or supplementing parts of a legislative act.

Falsified Medicines?

There has been an alarming increase in the number of medicinal products detected in the EU which are false representations of authorised medicines. The effects of falsified medicines in the supply chain can be numerous and extensive. These products usually contain sub-standard or false ingredients, no ingredients or ingredients in the wrong dosage, or pose a serious threat to human health.

In addition to this, it should be noted that pharmaceutical products of poor quality might contribute to the emergence of resistance to effective treatment. This is because when patients are treated with poor quality drugs, low bioavailability results in drug under-dosage, which in turn promotes the development of resistance. Therefore, product quality is an important consideration.

Falsified medicines are not to be confused with counterfeit medicines. The latter term refers to medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights. The Directive on ‘falsified medicines’ does not deal with this aspect.

Overall, the aim of the FMD is to ensure that trade in medicines is rigorously controlled to improve the protection of public health.

The FMD also contains significant measures relating to the introduction of safety features (serial numbers and/or tamper-evident seals) and more stringent rules for importation of Active Pharmaceutical Ingredients (APIs).

Safety

features

- New Phenomena!

A major aspect of the FMD is the requirement of safety features to be placed on product packaging and verified throughout the supply chain. There are plans for a new safety feature to be placed on individual packs for identification, as a guarantee of authenticity, to facilitate traceability and for determining whether there has been product tampering. This will also apply to repackaging where equivalent features will have to be affixed.

The European Commission will have to decide on these safety features via the Delegated Act procedure. These measures will apply to all prescription drugs unless they are specifically exempted, but not to non-prescription drugs, unless they are considered to be high risk.

What

is this

Safety Feature?

Track and Trace has been on the radar for some time in recent years. With the adoption of the FMD, track and trace and implementation of safety features is now a reality. There are many product verification options, including linear barcodes, 2D barcodes and Radio Frequency Identification 24

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Falsified Medicines Directive

(RFID). How these safety features are going to apply is still a question that needs to be answered. There are a number of proposed solutions and many countries have adopted forms of track and trace security systems. For example, data matrix is mandatory in Turkey since January 2009. France has also adopted a mandatory 2D matrix on its packaging, which became mandatory on January 1, 2011. We have also seen EFPIA’s coding and identification (Track & Trace) project in Sweden that was initiated in 2009: this involved scanning 11,000 packs in 25 pharmacies across Stockholm as part of a pilot project. Will the result of the FMD be a harmonised approach to product traceability within the EU? This has yet to be confirmed.

A German initiative called SecurPharm, a new track and trace pilot, has recently been announced, which involves placing unique serialised 2D matrix codes on medicines at the point of manufacture.

The SecurPharm pilot will make use of two separate databases, one accessible to the pharmaceutical manufacturers and the other to the pharmacists. Wholesalers will be able to have access to the databases, but only in cases where there is a potential breach in security: for example if a counterfeit medicine is suspected. This is an example, of an End to End System – packs scanned and authenticated by pharmacists at the point of dispensing – and is expected to get underway in January 2013. It is not sure what the outcome of this study could be, but it could serve as the model for European countries in the context of the recently adopted Directive on Falsified Medicines!

APIs may be imported into the EU only if they are accompanied by a written confirmation of GMP compliance by the regulatory authority in the country in which they were manufactured. Alternatively, the site of manufacture of the API can be included on a list that will be maintained by the European Commission. So what is this list? It is a list of countries with a regulatory structure for API that is equivalent to the EU. The regulatory authority providing the confirmation will also need to be audited by the EMA to ensure compliance with EU standards. Those deemed compliant will be placed on the list.

Protecting patients is the fundamental goal of the new Directive. At this time, it is difficult to foresee how this new legislation will impact the Pharmaceutical industry in terms of changes that will need to be made, for example, to the design and implementation of quality systems and vendor management systems. Costs that companies can expect to incur in complying with the new directive and impacts on the supply chain are also difficult to evaluate at this point.

There is no doubting that these changes will introduce many challenges for pharmaceutical operations! There are still a number of unanswered questions: for example, will this legislation also apply to veterinary products? Time will tell!

What does the Falsified Medicines Directive mean for GDP? The FMD also introduces new changes for wholesalers, brokers and APIs. There are now new requirements for ensuring supply chain security.

The legislation requires brokers to have quality and documentation systems and to keep records of what they sell and manage between other parties to ensure that those products are authorised for sale within the European Union.

Also newly covered in the legislation are distributors of active substances, who will now be required to register their activities and comply with API GDPs. Distributors who engage in parallel trade will also face major new changes to their businesses. The legislation will require that the parallel distributor removes the original safety features and replaces them with “something equivalent”.

About the Author ANN McGee B.Sc.(Pharm), M.Sc., MPSI is the Managing Director and Principal Consultant with McGee Pharma International, providing quality, regulatory compliance and training services and products to the pharmaceutical industry worldwide. Ann is a member of the Committee of the Irish Chapter of the Parenteral Drug Association (PDA) and of the European QP Association Expert Panel on GDP. Ann has 22 years experience working within the pharmaceutical industry and as a Regulator, including being Senior Inspector with the Irish Medicines Board and Registrar (CEO) of the Pharmaceutical Society of Ireland, as well as various positions in the areas of Product Development, Clinical Trials, Regulatory Affairs, Technical Management, Quality and Compliance. McGee Pharma International received a Highly Commended Award in the Services Category of the Small Firms Association National Business Awards 2012. Previous awards include Highly Commended Outstanding Small Business at the Small Firms Association National Business Awards 2011, Best Small Business 2011 at the Fingal Chamber Awards and winner of the Fingal County Enterprise Board Entrepreneur Award 2009.

Audits and Inspections Will Be Required for APIs Under the legislation, drug product manufacturers will be required to audit their API suppliers. While this has been an expectation for some time, the directive makes it a requirement. The QP for the finished product will need to include a certification within the QP declaration for each batch that an audit of the API manufacturer has taken place, and when it was carried out.

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Falsified Medicines Directive

Counting the Cost of the FMD Dr Rebecca Cramp, Scientific and Regulatory Affairs Manager, IPHA, examines the Falsified Medicines Directive and what it will mean for pharmaceutical manufacturers, wholesalers, brokers etc.

T

he implementation of the Falsified Medicines Directive (FMD, 2011/62/EU), is one of the key topics in 2012, both for the European Health Authorities and the Pharmaceutical industry.

The Directive is aimed at dealing with an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source.

Those products usually contain sub-standard or falsified ingredients, no ingredients or ingredients in the wrong dosage, thus posing an important threat to public health.

The Directive contains numerous provisions for strengthening the management and oversight of the upstream and downstream supply chains, including provisions for safety features on medicines, oversight and importation of active pharmaceutical ingredients (APIs) and oversight of ‘at-risk’ excipients, brokers and wholesalers.

In addition, the inspection and enforcement programme of European Agencies will be strengthened.

medicines are different from other counterfeit products due to their major public health implications and that the European Commission “stands fully behind the substance of this well-balanced agreement”, which introduces rigid measures, while being at the same time proportionate and flexible. This is crucial as “not all medicines are the same” and the likelihood of falsification / risks for public health vary accordingly.

With regard to APIs, the legislation strengthens cooperation and achieves a truly effective and workable system of inspections. Dalli acknowledged the importance of inspections but stressed that a huge percentage of APIs used in Europe comes from third countries; therefore, a selective approach is needed, based on cooperation with those having a very high level of standards and on inspections in those countries which are less proficient.

Taking Us To New Territory

Among the major changes for pharmaceutical manufacturers are more formal requirements to audit suppliers of API to ensure that they comply with GMP (including a solid legal basis for the qualified person delegation) and good distribution practice (GDP). Manufacturers, importers and distributors of API will be required to register with the regulatory body in the country where they are established, with registrations to be recorded in a database operated by the European Medicines Agency.

Other new tasks that the manufacturers must embrace under the Directive include assessing the risk to product quality of any excipients they use and informing the regulator and the Marketing Authorisation Holder if they receive information that products may be falsified.

Currently, exporters of medicines to third countries do not need to hold a wholesaler’s license. However, from January 2013, all those intending to export to third countries must hold an authorisation to do so, including organisations operating in free trade zones.

The Directive requires that certain safety features be included on individual medicinal products. The ‘unique identifier’ is one of the safety features “to verify the authenticity of the medicinal product and identify individual packs”, the other one being “a device allowing verification of whether the outer packaging has been tampered with” (‘tamper evidence’). With regard to ‘tamper evidence’, the choice of the technical specification is left to the manufacturer. Once the safety features are in place on product

Changes

European Commissioner for Health and Consumer Policy John Dalli indicated that the proposal would “take us to a new territory” as this is the first time that the European Union has tackled the threat posed by falsified medicines through a legislative measure that will make the European regulatory system fit for the future and will contribute to increased patient protection. Dalli noted that falsified

for

Pharma Manufacturers

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Falsified Medicines Directive

carry the safety features and non-prescription medicines do not. However, the delegated acts will set out the exceptions to the general rule: i.e. the list containing the prescription-only medicinal products or product categories which should not bear the safety features (white list), and the non-prescription medicines which should bear them (black list). Once the provisions are published, companies will then have three years to comply with the technical requirements.

A European industry consortium made up of associations (EFPIA, GIRP and PGEU) has developed a European Stakeholder Model (“ESM”) which is an endto-end, point-of-dispense coding and serialisation system, which allows pharmacists and other dispensing professionals to check a unique identification code on each individual pack when it is dispensed to the patient.

“The costs of all these provisions are likely to be substantial for the pharmaceutical industry and others in the supply chain.

However, the Directive is an important vehicle for decreasing the risk of falsified medicines reaching patients.”

packs, wholesale distributors will have to verify that products they handle are not falsified by checking the features are intact. They will also have to record batch numbers of products with safety features attached.

Brokers

of

Medicinal Products

The new legislation breaks new ground in that brokers of medicinal products will now be subject to regulatory controls and are likely to face considerable cost burdens in meeting the new requirements. Brokers are different from wholesalers in that they negotiate trade in pharmaceuticals on behalf of other parties, and do not physically handle the goods that they deal in. Under the new legislation, brokers operating before January 2013 must register with the competent authority by March 2013 and must have a permanent address in the relevant member state. They must supply details, including name, a telephone number and site contact details. Once registered, they will become the subject of inspections and an annual fee.

The new Directive also contains provisions aimed at protecting patients from receiving falsified medicines through the sale of medicines via the internet. Websites offering medicines must be linked to the website of the respective competent authority. Additionally, a list of all persons or bodies in that member state that are authorised to offer medicinal products for sale via the internet must be available on the competent authority website.

Furthermore, such web-pages must, in order to facilitate identification, display a common logo.

The system is composed of a European central hub, connected to a series of national or regional data repositories that serve as the verification platforms that pharmacies and other authorised parties can use to check a product’s authenticity. The codes are generated and applied by manufacturers using a 2D data matrix barcode, which contains a unique serial number. Uniquely, the system will constitute an end-to-end, real-time verification tool, enabling: manufacturers to upload serial data; wholesalers, pharmacists etc. throughout the supply chain to verify that a product is genuine; parallel distributors to decommission individual codes and upload new codes (linking the new code to the old code at batch level); and HCPs to decommission individual codes. The proposed system should accommodate different needs in different regions, but be based on common principles to ensure mandatory coding and verification of products, in line with a harmonised coding system.

Not unsurprisingly, the costs of all these provisions are likely to be substantial for the pharmaceutical industry and others in the supply chain. However, the Directive is an important vehicle for decreasing the risk of falsified medicines reaching patients and IPHA member companies are committed to its successful implementation.

Provisions: The White List & Black List Member States are required to transpose the Directive into their national legislation by January 1, 2013. With respect to implementation, the Commission will set out the implementing rules in a set of so-called Delegated Acts, Implementing Acts or Guidelines. The provisions of the Directive require that in general, prescription medicines 28

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Life Sciences

The Changing Face of Life Sciences in Ireland ENA Prosser, Fountain Healthcare Partners, examines the changing nature of Life Sciences in Ireland and calls for a coherent voice to represent the entire sector.

A

sk a financial journalist about ‘Life Sciences’ in Ireland and they can quote impressive statistics. Blockbuster drugs and medical devices like stents have generated as much as 50% of national exports. The promise of high value jobs helps lure students into careers in science and engineering. The wide distribution of significant infrastructure in centres in Cork, Galway, Dublin and throughout the country spreads economic activity widely. Ireland works hard to attract and develop an internationally significant pharmaceutical, chemical and medical device hub.

In a time of high unemployment in Ireland, IDA Ireland’s website notes that Life Science companies in pharmaceutical, biotechnology, medical devices and diagnostics, employ 47,288 people between indigenous and multinational companies in a variety of activities. But, times are changing internationally and the business model of internally-driven Life Science innovation is broken. So, where are we going for the next 20 years?

Embracing Change

in

Life Sciences

Ena Prosser, Partner at Fountain Healthcare Partners.

How to embrace changes in Life Science companies everywhere – including Ireland? New pipeline products are now bought-in from smaller innovative companies when it is de-risked, it is not necessarily grown within the company.

Several of the Top 10 pharma companies who have plants in Ireland are reeling from the financial implications of end or near-end of their top grossing patents. Device, pharma and biopharma companies are learning the true meaning of “pharmacoeconomic assessment” as Governments restrict access to expensive drugs.

The question is how does Ireland respond to this challenge, remain competitive and ensure we grow the pipeline of attractive products and investments to feed the sector. The challenge is to reposition, retain and retrain the talented people who are at the heart of the sector in Ireland, as we look to capitalise on newer products. The bottom line is that we can’t take this sector for granted and Ireland needs to move in tandem with Global Life Science companies as they become more mobile, more nimble and more cost sensitive organisations.

Recent Successes The news is not all bad. Business is happening and significant commercial deals by Irish companies are impressive.

Sometimes the significance of major commercial transac29

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Life Sciences

tions is not fully appreciated by researchers, scientists and engineers. The relevance of these commercially vibrant companies is noted on the financial pages, more than the innovation and science media, and we need to change this! For example, the last 18 months have marked some significant deals involving Irish companies involved in next generation product development and sales. Many of these companies are not clients of the IDA or Enterprise Ireland and yet these companies represent a fantastic engine of income generation for Ireland.

A notable transaction in January 2012 was made by Azur Pharma, which (to quote The Irish Times) “was swallowed whole” by Nasdaq-listed Jazz Pharmaceuticals. No cash changed hands. Instead, shareholders in Azur were given a significant percentage of the combined entity. Some of Azur’s ex-Elan founders joined Jazz and the larger company will be domiciled in Ireland, a move that should prove beneficial from a tax point of view in the years ahead and should encourage growth in earnings and jobs.

Venture capital-backed companies like Amarin have seen significant clinical and financial success for investors from the progress of the lead candidate AMR-101. Amarin is developing AMR101, a prescription-grade omega-3 fatty acid, as a prescription medicine for the treatment of patients with very high triglyceride levels.

Bioniche Pharma, based in Connemara, was acquired in late 2010 by US-headquartered Mylan Inc. This did not mark the end of Bioniche. Acquisition of an Irish company by a multinational is not a bad thing, as in April 2012, Mylan/Bioniche announced a significant expansion of the company’s Galway base. The investment made sense as the acquisition enabled Bioniche’s market entry into the North American injectables market and a platform for the commercialisation of future biosimilar products. This pattern is replicated from previous years where DiaSorin acquired Biotrin and grew in Ireland.

Ireland’s ‘homegrown’ multinational, Elan also enters a new chapter, with the sale of the original drug delivery and manufacturing business to Alkermes, who are also now an Irish-US company, with significant employment in Athlone and headquarters in Dublin.

Device companies like Biancamed were sold to large players, returning profits to management and to shareholders like Enterprise Ireland, Invest Northern Ireland, ResMed, UCD and venture capital backers. Similarly in 2010, Creganna acquired Tactx Medical Inc. to become CregannaTactx Medical. This enlarged company now operates from a tri-continent network and is ranked among the global Top 10 providers of medical device outsourcing solutions.

Each of these deals is significant but taken together, these deals demonstrate an increasing commercial and technical sophistication in the Irish Life Science management teams. We have the entrepreneurial talent to grow and develop Irish companies - as well as developing new ideas for multinational companies.

This local activity is balanced by continued investment across the country in next generation manufacturing at companies like Eli Lilly in Cork, who are investing €330m in a new Biopharmaceutical facility; like Allergan Pharmaceuticals’ $350m expansion of their Mayo facility and Genzyme’s continued commitment to enhancing their Waterford facility. All investment like this is extremely welcome.

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Life Sciences

means that the separate groups of the Life Sciences sector almost compete with each other for investment, research strategy and for talent.

A case in point is Ireland’s €500m Research Prioritisation Plan, launched by Ministers Bruton and Sherlock in March 2012, where there was some support for elements of Life Sciences, such as drug delivery, process technologies and for medical devices. The process and industrial input did not include a strong voice for pharma research and this was a missed opportunity to enhance research collaboration and innovation with the pharma research sector and a small number of world-class research teams emerging from our university bioscience and clinical research colleagues.

Change In Priorities?

A Single Sector

but a

This change in priorities is somewhat curious, given the investment policies and actions by the sector on the ground. It is at odds with the fact that Enterprise Ireland and NPRF are funding key international venture capital funds, such as Sofinnova, to develop biotechnology-based companies from our science base and companies.

Venture capital funds and angel investors based in Ireland continue to invest in university spin-outs like Opsona, Genable, Tri Mod and Trino Therapeutics.

Similarly, Elan Corporation, has donated €3m to UCD to fund the setting-up of a high-level academic position, as well as scholarships and a lecture series for seven years.

The Chair of Business of Biotechnology is Europe’s first and reports in the financial sections in The Sunday Times indicate that some of the cash will also go to UCD’s new science centre.

Fragmented Voice?

Despite a number of efforts, no single group represents the full spectrum of Irish Life Sciences - from our finance gurus to our engineers. The Irish Medical Device Association (www.IMDA.ie) is a good model to share across the broader Life Science sector, with a common voice and great co-operation between the multinationals and Irish companies, between researchers and government agencies. If we take the academic research community and add these people to employee numbers in Life Sciences, we can see that there are 50,000+ people, with lots of activity and lots of energy, but in reality this is fragmented.

The important manufacturing community is largely represented by PharmaChemical Ireland (www.pharmachemireland.com), while the Irish Pharmaceutical Healthcare Association (www.ipha.ie) represents the international research-based pharmaceutical industry in Ireland, and smaller innovative companies are represented by the Irish BioIndustry Association (www.ibia.ie).

This fragmentation hampers internal mobility of people and ideas and the optimum cross fertilisation of ideas into newer areas and fundable investments. We need to ‘mix-up’ and refresh the Life Science ecosystem which includes diverse skill-sets, from our licensing lawyers to our scientists, our venture capitalists to entrepreneurs, regulators and engineers. Aside from manufacturing, we have really terrific speciality pharma, emerging biotech and device companies and a robust and internationally important pharma services sector. This diversity of voices

What’s Ahead

for

Life Sciences?

Life Sciences in Ireland has world class manufacturing at its heart. For the next couple of years, our sector needs to foster the creativity, innovation, stamina and entrepreneurship that is in our souls! For the times…. they are a changing.

About the Author: ENA Prosser is a Partner in Fountain Healthcare Partners. Fountain’s main office is in Dublin, Ireland, with a second office in New York, USA. Ena was part of the team that raised Fountain Healthcare Partners I fund, a dedicated Life Science venture capital fund which launched with €75m ($116m) in April 2008.

Ena has a strong innovation policy background and is currently a member of the Irish Government Innovation Taskforce in Intellectual Property, as well as the Irish BioIndustry Association. She is a board member of ophthalmology research charity Fighting Blindness, Genable Ltd, Trino Therapeutics Ltd. Ena is an Adjunct Professor at University College Dublin.

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Traceability

Movianto Scores with Zetes System Zetes’ TotalProof solution ensures full traceability during the transportation of temperature-sensitive products, and was the perfect solution for leading pharma logistics provider Movianto.

M

ovianto, logistics service provider to the pharmaceutical, biotechnology and healthcare industry, has implemented Zetes’ TotalProof solution to ensure full traceability during the transportation of temperature-sensitive products and to optimise customer service. Companies using Movianto’s services now benefit from real-time information exchange and complete traceability during transportation, with real-time visibility confirming the status of their merchandise.

Movianto’s active refrigerated transport network spans the entire Iberian Peninsula. It is the only certified active refrigerated transport network dedicated to the pharmaceutical sector. To comply with strict health and safety regulations, products delivered by Movianto require reliable temperature control during transportation.

The company contacted Zetes in order to achieve the highest quality of service in its distribution network, which offers 24-hour delivery services to its clientele of wholesalers and hospitals throughout Spain and Portugal.

“For us, Zetes offers a true benchmark in industrial mobility because it is so familiar with the transport sector and its needs,” notes José Revilla, Operations Manager of Movianto. “It has helped us achieve our goal of offering excellence in our services, operating in sensitive markets like pharmaceuticals and healthcare, and in minimising costs and risks.”

comply with very strict safety rules. Traceability plays an important role in ensuring quality products and services within the industry. Zetes constantly invests in solutions that cover all their identification and data capture needs, from production to end consumer, over warehousing and transport and logistics, even in the most challenging environments. Of all sectors, this is one where having A to Z traceability is an absolute must.”

Identification

and

Mobility Solutions

Zetes is a leading provider of identification and mobility solutions to optimise the supply chain. Through intelligent use of automatic identification technologies, Zetes links the movement of products or people with new and existing IT systems. The result is a perfect exchange of information for customers, with data acquired during every stage in a process and available in real time. In this way, Zetes solutions provide businesses, public institutions, and governments with track and trace capabilities, both within and outside their facilities, thus enabling them to optimise overall performance, balance their accounts more efficiently and master the most demanding traceability challenges.

For more information, see www.zetes.ie

Reducing Expenses & Increasing Efficiency Levels After analysing Movianto’s needs and studying its operations, Zetes customised its TotalProof mobility solution, based on a requirement for proof of pick-up and delivery.

The solution allows Movianto to manage and optimise the loading of trucks, deliveries, transfer of packages from one distribution centre to another, and to manage its fleet of vehicles by organising the routes taken by their mobile workers. Carriers use mobile devices to communicate in real time via the Movianto transport management system, thus ensuring accurate data input and maintaining realtime visibility of operations.

According to José Revilla, “Through this solution, we have acquired new capabilities. We are now able to optimise other related business processes, and we have made the delivery service profitable by reducing its expenses and increasing the levels of efficiency in customer service.”

Alain Wirtz, CEO of Zetes concludes, “Companies from the pharmaceutical and healthcare sector have to 32

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Irish Advert - pharma_HR.pdf

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IRELAND’S LEADING PARTNER IN IDENTIFICATION AND MOBILITY SOLUTIONS FOR PHARMACEUTICALS C

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Datamatrix marking and Serialisation

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Integrated Labelling Solutions

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Complete traceability

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Shipping Verification Increase accuracy and productivity with Voice order picking

Traceability from package to pallet and beyond

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www.zetes.ie

Unit 1 Coolport Coolmine Industrial Estate Blanchardstown Dublin 15

The National Technology Park Lonsdale Road Plassey Limerick

T: +353 (0) 1 885 0240

T: +353 (0) 61 502 924

Temperature Data Collection Services Ltd. (TeDaC) offer a full temperature & humidity mapping service to pharmaceutical manufacturers & distributors for compliance with GMP & GDP regulations.

Important areas for temperature & humidity mapping; • Raw materials • Retained Goods • Cold stores and freezers • Warehousing • Finished Goods • Packaging • Incubators • Refrigerated Vans Reports on completion of mapping are suitable for presentation to IMB & FDA auditors.

For more information contact us on Tel : 0044 (0)117 9104821 Mob : 0044 (0)7515660775 or email info@tedac.co.uk

www.tedac.co.uk

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Logistics

Johnston Logistics: Leading the Way Johnston Logistics has evolved from a traditional domestic haulier to a true pan-European logistics provider.

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ohnston Logistics, specialists in Contract logistics, European Logistics and Domestic Distribution, operates from seven sites within Ireland, including the company headquarters and administration hub, based on a three-hectare site in Dublin’s Rathcoole.

They operate from a modern Hi-Bay warehouse facility. The key to the efficient running of this facility is investment in the very latest technology, which allows Johnston Logistics to deliver a world class service to their customers.

Within the company’s warehouse division, Johnston Logistics operate ambient, ATEX and temperature controlled areas with temperature monitoring alarm systems.

This ensures the products are stored at the appropriate temperature. The company operates a comprehensive Warehouse Management System, which allows for real time stock visibility and transparent tracking and traceability. All warehouse transactions are through real-time bar code scanning under digital CCTV, allowing clear order pick visibility.

The Dublin site is also an Authorised Consignee Premises for Bonded non-EU dry goods: this entails the storage, clearance and management of products incurring duty.

Johnston Logistics holds an Irish Medicines Board Wholesalers Licence, operating to GDP Standards. This has allowed the company further expand the range of

Johnston Logistics holds an Irish Medicines Board Wholesalers Licence, operating to GDP Standards, which enables the storage and transportation of active ingredient and finished product.

logistics services offered to the Pharmaceutical and Life Sciences sectors, including the storage and transportation of active ingredients and finished products.

Hazardous Goods The company has considerable expertise in dealing with hazardous goods. To facilitate this, they have a full time QHSE manager, who is also the on-site DGSA, which ensures ADR and IMDG compliance. There is a clear and concise Health and Safety culture within the company. Johnston Logistics is ISO 9001:2000 and SQAS accredited.

Sustainability is core to the business, and amongst some of the initiatives undertaken by Johnston Logistics is rain water harvesting, which supplies water to an automatic truck wash, which in turn recycles 95% of its water, thus helping to reduce the company’s carbon footprint.

Pan-European Logistics Provider Johnston Logistics have made the transition from being a traditional domestic haulier to a true pan-European logistics provider, while retaining the quality and service levels of a local organisation.

They have remained ahead of the curve with their focused expansion into mainland Europe, spearheaded by their exclusive partnership with a major European logistics service provider – Dachser GmbH. The Dachser network allows them to offer worldwide logistics solutions, supported by world-class customer service.

“Johnston Logistics service provides Irish companies with a global network and global companies with an Irish network,” sums up a company spokesperson.

Johnston Logistics operate from a modern Hi-Bay warehouse facility.

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WE CREATE COMPETITIVE ADVANTAGE FOR OUR CUSTOMERS BY OPTIMIZING THEIR PERFORMANCE WITH FLUID CONTROL TECHNOLOGY YOU CAN SEE OUR THINKING

With a deep understanding of the Life Science sector, Norgren has expertise in precision gas and liquid control, dispense, automation, and proportional solenoid valves.

We provide fully integrated solutions, and discrete components to deliver the precise control, repeatability, minimum dead space, and safety requirements of our Life Science customers.

Our range of high quality, modular products, and dedicated design and engineering resources is backed by the four leaders in precision fluidics – Kloehn, FAS, KIP & Norgren.

ENGINEERING ADVANTAGE Pumps, Syringes & Solenoid Valves

Fluidic Control Valve

Laminate Manifolds

For further information visit www.norgren.com/ie or contact Paul Shankey – Sales Manager (++ 353 (0)87 2578161, pshankey@norgren.com)

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Product Identification Standards

GS1 Raises the Bar GS1 can help you to uniquely identify your products and comply with EU regulations, such as the Falsified Medicines Directive and UDI regulations.

GS1’s track and trace solution is already in use in the treatment of Haemophilia patients at the National Centre for Hereditary Coagulation Disorders (NCHCD), St James’ Hospital, Dublin.

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n a recently published shared vision for product identification, the European Federation of Pharmaceutical Industries & Associations (EFPIA) is supportive of the use of GS1 standards for the identification of products. A 2D GS1 DataMatrix is the data carrier of choice, encoded with a product code, serial number, batch number and expiry date. This information should be encoded using the relevant GS1 application identifiers (AI). In this respect, EFPIA’s vision is aligned with the objectives of GS1 and its members. In fact, this solution is already proven and in use here in Ireland for the track and trace solution in the treatment of Haemophilia patients at the National Centre for Hereditary Coagulation Disorders (NCHCD), St James’ Hospital, Dublin.

The choice of GS1 Standards has been driven by a broad number of factors, including but not limited to: • Patient safety – globally unique codes and certainty of product identification; • Interoperability – ability for the proposal to work across markets, stakeholders and sectors; • Complexity reduction – one solution which can be leveraged for all levels of packaging with ability to choose the appropriate symbology;

• Technical suitability – factors such as robustness of data carrier, ability to print online, etc; • Cost effectiveness of solutions – appropriate for needs of users; • Flexible and future compatibility – part of an on-going standard which will not be superseded; • Proven solution - used in the retail sector worldwide.

The Advent

of

GTIN

Product identification must ensure that an item, e.g. a pack, can be globally identified through a unique identifier, so as to prevent different products from having the same identifier, which would ultimately lead to harming patients and increasing costs for the healthcare provider.

The GS1 product identifier is called GTIN (Global Trade Item Number) and can be used across countries without any restrictions or errors: this means that no trade barriers are created, which would otherwise potentially impact patient care and safety, when products cannot be identified. There are many other benefits of a global approach, such as the possibility to enable traceability within the EU and interoperability within and across other sectors.

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Product Identification Standards

The GTIN is used today by many industries to uniquely identify all levels of packaging for a given product, from pallet, shipper, carton, and retail pack to single unit. It guarantees uniqueness of numbers across all markets, sectors, companies and products. Companies worldwide have used the GTIN for many years on retail packs in barcodes for product identification at point-of-sale as well as for moving products through the supply chain. GS1 Healthcare has recently started a global work effort to develop standards for the identification on unit dose level with GS1 standards.

(Spain) have been approved.

Through the global Healthcare User Group (HUG), GS1 has provided a neutral, user-driven forum for the last six years for all healthcare supply chain stakeholders to meet and develop the necessary standards.

Scan this QR code to see a short The GS1 system of standards enables video of the track and trace solution in St James’ hospital. all stakeholders to efficiently and effectively meet the requirements for the Falsified Medicines and UDI (Unique Device Identification) regulations.

National Numbers The biggest obstacle to GS1’s vision was the fact that some countries have national numbers for pharmaceutical product identification, which are not compatible with a pan-European approach to serialisation. However, GS1 Standards cater for national numbers to be utilised within the GS1 standards. This allows, for example, a GTIN and national number to be held in the same barcode so that both can be captured with a single scan. In order to facilitate national numbers within the GS1 standards, they are represented in a specific format. In such cases, both the GTIN and the national number are incorporated in the healthcare for PZN magazine:Layout 14/05/2012 Page barcode.

Toaddate, (Germany),1 CIP (France)17:08 and CN

GS1 has published a position paper on the pending EU Directives for both Falsified Medicines (Shared vision with EFPIA) and UDI Implementation which is available at: www.gs1ie.org 4

Do you need to know more about the pending EU Directives on Falsified Medicines and UDI (Unique Device Identification)?

Do you strive to maximise Efficiency and Patient Safety?

Do you wish to learn more about how GS1’s globally used standards and solutions can help you to uniquely identify your products and comply with EU regulations?

If you would like to talk to a GS1 Standards advisor please contact us today.

Do you need to fulfill a requirement for Identification, Authentication or Traceability?

We will be hosting a series of workshops and individual sessions to update manufacturers, suppliers and other interested parties on how the Directives will impact you.

Check our website for more details.

2nd Floor The Merrion Centre, Nutley Lane, Donnybrook, Dublin 4, Ireland T +353 (0)1 208 0660 F +353 (0)1 208 0670 E info@gs1ie.org W www.gs1ie.org

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INGREDIENTS

YOUR SUPPLY PARTNER:

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renntag Pharma is a significant supply partner to the pharmaceutical market sector, supplying an extensive range of products, including basic chemicals, excipients, intermediates and APIs. Brenntag is committed to providing solutions to help address the challenges faced by the pharmaceutical industry through an extensive portfolio and outstanding full service offering. Brenntag Pharma has an ever-growing commercial team of technical experts and industry experts with many years’ experience.

Brenntag also recognises that there are many other factors that are becoming of increasing importance to their pharmaceutical customers. These include access to low-cost but innovative producers, warehouse capacity restrictions, and supply chain simplification through supplier rationalisation.

WORLD CLASS SUPPLIERS From its strategically placed depots in Dublin and Belfast, with access to sea-fed facilities, Brenntag Pharma provides the local Irish market with global access to a comprehensive range of specialty ingredients and world class manufacturers.

Brenntag Pharma is able to share its knowledge with business partners and provide cost-effective supply chain management solutions to on-going projects. Brenntag Pharma delivers safe and effective substances from the best sources around the world.

TRULY SAFE PRODUCTS When we think of health, we automatically think of safety.

Brenntag understands that when it comes to the production of pharmaceuticals, every step, from source to final customer, must be undertaken using quality products that are safe, effective and fully comply with the demanding traceability and compliance requirements of the pharmaceutical industry.

Brenntag UK & Ireland – part of the Brenntag Group, the world’s leading chemical distributor

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Local service - national identity - global position

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Brenntag Pharma Ireland is committed to providing solutions to help address the challenges faced by the Irish pharmaceutical market.

We understand when it comes to the production of pharmaceuticals, every step from the source to the end customer needs to be suitable, reliable and safe.

Our strategically placed depots in Dublin and Belfast, in conjunction with a dedicated and growing pharma team, can provide a full service including product supply and sourcing, custom logistics solutions and full technical, compliance and regulatory support.

For more information please contact: Brenntag Dublin Tel: ()   Email: dublin.sales@brenntag.ie Brenntag Belfast Tel: + ()   Email: belfast.sales@brenntag.co.uk www.brenntag.com

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Code

of

Practice

Revised Code of Marketing Practice

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A guide to the revised IPHA Code of Marketing Practice for the pharmaceutical industry.

n mid-2010, the European and/or equipment, staff secondFederation of Pharmaceutical ment etc. However, edition 7.5 Industries and Associations of the IPHA Code requires that (EFPIA) Board agreed a the list include a description of Leadership Statement on Ethical the nature of the support that is Practices. It called for action to sufficiently complete to enable ensure that our industry continues the average reader to form an to uphold the highest standards in understanding of the significance its relations with healthcare profesof the support. sionals and with patient organisaSpecific criteria must be met tions and restricted the provision of where a member contracts servsamples. ices from a patient association, As the Irish member of the including written contract, legitiEFPIA, the Irish Pharmaceutical mate need, record maintenance, Healthcare Association (IPHA) reasonable service compensation is required to amend its Code to and public disclosure of the total take into account revised EFPIA amount paid per patient assoguidance. Thus a revised IPHA ciation over the reporting period.

Code of Marketing Practice for Also, IPHA members may now the Pharmaceutical Industry was extend hospitality to a bona fide introduced on January 1, 2012, ‘carer’ of a participant if the parincorporating the new EFPIA proticipant has clear health needs visions relating to samples (Clause (e.g. disability) and may con13) and increased transparency in tribute to the drafting of patient Dr Rebecca Cramp, Scientific and Regulatory Affairs association text from a fair and balinteractions with patient associaManager, IPHA. tions (Annex III). In this revision, anced scientific perspective, upon IPHA also introduced additional the request of patient associations. requirements to ensure that members would meet all their Additionally, the new Code introduces notifying pharmacovigilance obligations (Clause 12). requirements to ensure that members meet all their pharNow, each healthcare professional may receive, per macovigilance obligations. year, not more than four medical samples of a particular new medicine he/she is qualified to prescribe for two years after he/she first requested samples of each particular new Pre-Empting Legislative Requirements medicine.

Commenting on the revised Code, IPHA’s Scientific and Support to Patient Associations Regulatory Affairs Manager, Dr Rebecca Cramp, said: “Our members continue to be committed to upholding Previously, each IPHA member was required to make the highest standards of conduct in their relations with public a list of patient associations to which it provided healthcare professionals and patient associations in Ireland. financial support and/or significant indirect/non-financial Societal and patient needs change and our updated Code support, including a short description of the nature of reflects those changing needs and pre-empts upcoming support to those patient associations - indirect financial legislative requirements. These changes will lead to a more support includes donation of services from public relastreamlined system of self-regulation, not only in Ireland, tions, event management and market research agencies but also across the EU to the benefit of all citizens.” etc., while non-financial support includes provision of Copies of the revised Code are available from IPHA free training by company personnel, donations of facilities or can be downloaded at www.ipha.ie.

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C h e m ic a l S u pp l i e r s

Irish PharmaChem 2012

Chemical Suppliers Acids & Alkalis Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemsource Industrial Division Chemsource Logistics Corcoran Chemicals Ltd Fisher Scientific Goulding Chemicals Ltd National Chemical Co. Ltd Ocon Chemicals Ltd P.K. Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar Ltd

Biochemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Fisher Scientific Ocon Chemicals Ltd

Biocides Brenntag Ireland Camida Ltd Fisher Scientific Heterochem Dist Ltd National Chemical Co. Ltd Ocon Chemicals Ltd Univar Ltd

Catalysts Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Corcoran Chemicals Ltd National Chemical Co. Ltd P.K. Chemicals Ltd

Chiral Compounds Associated Chemicals Ltd Camida Ltd National Chemical Co. Ltd Waters Chromatography Ireland

Excipients Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemsource Industrial Division Chemsource Logistics Corcoran Chemicals Ltd Heterochem Dist Ltd National Chemical Co. Ltd Ocon Chemicals Ltd P.K. Chemicals Ltd Univar Ltd

Fine Chemicals Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Carbon Group Fisher Scientific National Chemical Co. Ltd Ocon Chemicals Ltd P.K. Chemicals Ltd Solv-Echem Ireland Ltd Univar Ltd

Gases Corcoran Chemicals Ltd Ocon Chemicals Ltd

Heterocyclics Camida Ltd National Chemical Co. Ltd

Inorganic Chemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemsource Industrial Division Chemsource Logistics Fisher Scientific Heterochem Dist Ltd LanganBach Servces Ltd National Chemical Co. Ltd Ocon Chemicals Ltd P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar Ltd

Laboratory Reageants Brenntag Ireland Carbon Group Fisher Scientific LanganBach Servces Ltd National Chemical Co. Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Waters Chromatography Ireland

Misc. Chemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemsource Industrial Division Chemsource Logistics Corcoran Chemicals Ltd Fisher Scientific Heterochem Dist Ltd National Chemical Co. Ltd P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar Ltd

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Oils, Fats and Waxes Associated Chemicals Ltd Brenntag Ireland Carbon Group Corcoran Chemicals Ltd Heterochem Dist Ltd National Chemical Co. Ltd Ocon Chemicals Ltd P.K. Chemicals Ltd Univar Ltd

Reagents

Organic Intermediates Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemsource Industrial Division Chemsource Logistics Fisher Scientific National Chemical Co. Ltd Ocon Chemicals Ltd Univar Ltd

Organometallics

Camida Ltd National Chemical Co. Ltd

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Fisher Scientific LanganBach Servces Ltd National Chemical Co. Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Univar Ltd Waters Chromatography Ireland

Silanes

Solvents Betco Marketing Ltd Brenntag Ireland Camida Ltd Carbon Group Chemsource Logistics Corcoran Chemicals Ltd Fisher Scientific Heterochem Dist Ltd National Chemical Co. Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Soltec (Ireland) Ltd Solv-Echem Ireland Ltd Univar Ltd Waters Chromatography Ireland

C h e m ic a l S u pp l i e r s

Irish PharmaChem 2012

Surfactants

Brenntag Ireland Camida Ltd Carbon Group National Chemical Co. Ltd P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Univar Ltd

Associated Chemicals Ltd

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Corcoran Chemicals Ltd Fisher Scientific Heterochem Dist Ltd LanganBach Servces Ltd National Chemical Co. Ltd Univar Ltd

Ireland’s Raw Materials Specialists Heterochem (Dist.) Ltd is the speciality raw material & excipient supplier of choice to the Pharmaceutical industry in Ireland.

• Antioxidants • Disintegrants • Emulsifiers • Colorants & Flavours • Preservatives • Sequestrants • Solvents • Starches • Sweeteners • Vitamins • Other Excipients Benefits to your business: • High quality, competitively priced products - ISO 9001 accredited • Excellent customer service - before and after the sale • A reliable and efficient sourcing partner • A highly qualified sales team of chemists available to assist with any technical queries • Prime location in Baldoyle, Dublin - close proximity to all distribution channels • On site storage of all raw materials in our controlled warehousing • Variety of UN approved pack sizes available: 25kg, 50kg, 200kg barrels & 1000kg Unit 49 Baldoyle Industrial Estate, Baldoyle, Dublin 13, Ireland T. +353 1 839 3127 F. +353 1 832 5746 E. info@heterochem.ie W. www.heterochem.com

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Irish PharmaChem 2012

G e n e r a l S u pp l i e r s

General Suppliers Actuators Airpower Festo Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Tyco Valves & Controls Ireland Ltd

Aerators

Analytical Equipment P.J. Boner & Co. Ltd Endress + Hauser (Ireland) Ltd Fisher Scientific LABPLAN Particular Sciences Ltd Petrochem Pipeline Supply Ltd PPD Inc. Sartorius Mechatronics Ltd SciChem - Cork SciChem - Dublin Weber Labelling & Coding

Manotherm Ltd WrenTech Ltd

CPI Technology Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd Quitmann O’Neill Packaging Ltd WrenTech Ltd

Air Filtration/Monitoring / Pollution Control Airpower Flexachem Manufacturing Ltd Norgren Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

Alarms P.J. Boner & Co. Ltd

Analysis Services Anecto Catalent Pharma Solutions Indaver Ireland Lancaster Laboratories

Barriers Safety

Biotechnology

GS1 Ireland

Autoclaves Fisher Scientific Goliath Packaging Systems Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

Automation Airpower P.J. Boner & Co. Ltd Bosch Rexroth Ltd Festo Ltd Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd LABPLAN Lister Machine Tools Ltd Norgren Ireland Ltd O’Flynn Medical Ltd Pilz Ireland Weber Labelling & Coding

Aluminium Products Flexachem Manufacturing Ltd

Airpower Fisher Scientific Goliath Packaging Systems Ltd GS1 Ireland Indaver Ireland Millmount Healthcare

Fisher Scientific

Associations Agitators

Barcoding/Labelling/ Traceability

Brenntag Ireland Callaghan Engineering Catalent Pharma Solutions Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd H.R. Holfeld (Engineering) Ltd LABPLAN Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin Waters Chromatography Ireland

Blenders Fisher Scientific Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Blistering / De-Blistering Catalent Pharma Solutions

Balances P.J. Boner & Co. Ltd Fisher Scientific Irish National Accreditation Board Ocon Chemicals Ltd Sartorius Mechatronics Ltd SciChem - Cork SciChem - Dublin

Blowers Airpower CPI Technology Ltd Flexachem Manufacturing Ltd

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Bursting / Rupture Discs CPI Technology Ltd Flexachem Manufacturing Ltd

Cabinets Airpower Cross Technical Solutions Festo Ltd Fisher Scientific ProSys Containment and Sampling Technology Sartorius Mechatronics Ltd

CAD Callaghan Engineering Norgren Ireland Ltd Waters Chromatography Ireland

Calibration P.J. Boner & Co. Ltd Dalkia Endress + Hauser (Ireland) Ltd Fisher Scientific Flexachem Manufacturing Ltd Irish National Accreditation Board Ocon Chemicals Ltd Sartorius Mechatronics Ltd Waters Chromatography Ireland

Chromatography Fisher Scientific Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin Waters Chromatography Ireland

CPI Technology Ltd Enva Ireland Ltd Fisher Scientific Idex Pump Technologies (Ireland) Ltd LABPLAN Sartorius Mechatronics Ltd SciChem - Cork SciChem - Dublin

Chemical Consultants Hazchem Training Ltd Pilz Ireland Soltec (Ireland) Ltd

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

Condition Monitoring

Cleanrooms Cross Technical Solutions Dalkia Millmount Healthcare Ocon Chemicals Ltd Pilz Ireland WrenTech Ltd

Clinical Reasearch Organisation HRB Clinical Research Facility Java Clinical Research Ltd

Cleaning Services / Equipment Goliath Packaging Systems Ltd Ocon Chemicals Ltd WrenTech Ltd

Cold Chain Packaging Centrifuges

Condensors

G e n e r a l S u pp l i e r s

Irish PharmaChem 2012

Catalent Pharma Solutions CRS Mobile Cold Storage Millmount Healthcare Movianto Ireland

Compressed Air/ Compressors Airpower Dalkia Festo Ltd Idex Pump Technologies (Ireland) Ltd

Computer Systems

P.J. Boner & Co. Ltd CPI Technology Ltd Dalkia Flexachem Manufacturing Ltd

Construction Management Callaghan Engineering

Conveyors Bosch Rexroth Ltd Goliath Packaging Systems Ltd Weber Labelling & Coding WrenTech Ltd

Cooling Systems CPI Technology Ltd Cross Technical Solutions Dalkia Dawsonrentals Irl Ltd

Data Acquisition P.J. Boner & Co. Ltd Endress + Hauser (Ireland) Ltd GS1 Ireland Manotherm Ltd Waters Chromatography Ireland Weber Labelling & Coding

Design Cross Technical Solutions Graham Hart (Process Technology) Ltd Pilz Ireland

Ocon Chemicals Ltd Premier Validation 43

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Irish PharmaChem 2012 G e n e r a l S u pp l i e r s

Dispersers Fisher Scientific Ocon Chemicals Ltd WrenTech Ltd

Distillation CPI Technology Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Ocon Chemicals Ltd Soltec (Ireland) Ltd WrenTech Ltd

Drains Airpower Enva Ireland Ltd H.R. Holfeld (Engineering) Ltd Norgren Ireland Ltd

Driers Airpower Complas Packaging Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Norgren Ireland Ltd WrenTech Ltd

Drums/Containers C+G Logistics Group Carbon Group Chemsource Industrial Division Complas Packaging Ltd Indaver Ireland Industrial Packaging Ltd Interpac Ocon Chemicals Ltd Quitmann O’Neill Packaging Ltd WrenTech Ltd

Economic Development Agency Invest Northern Ireland

Education & Training Ann McGee CPI Technology Ltd Festo Ltd GS1 Ireland Hazchem Training Ltd Henley Forklift Group Ltd Pilz Ireland Waters Chromatography Ireland

Effluent Monitoring/ Treatment Axium Process P.J. Boner & Co. Ltd Carbon Group Endress + Hauser (Ireland) Ltd Enva Ireland Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd Lancaster Laboratories Ocon Chemicals Ltd

Electrical Airpower Callaghan Engineering P.J. Boner & Co. Ltd

Electronic Components Airpower Pilz Ireland

Energy Efficiency / Management Berkley Group Callaghan Engineering Dalkia Endress + Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Irish National Accreditation Board Norgren Ireland Ltd Ocon Chemicals Ltd Sustainable Energy Authority of Ireland

Callaghan Engineering Croom Precision Medical Cross Technical Solutions Dalkia Henley Forklift Group Ltd LABPLAN Pilz Ireland

Environmental Consulting Callaghan Engineering Dawsonrentals Irl Ltd Enva Ireland Ltd Ocon Chemicals Ltd Pilz Ireland

Environmental Services/ Equipment P.J. Boner & Co. Ltd Callaghan Engineering Enva Ireland Ltd Flexachem Manufacturing Ltd H.R. Holfeld (Engineering) Ltd Idex Pump Technologies (Ireland) Ltd Indaver Ireland Ocon Chemicals Ltd Pilz Ireland Quitmann O’Neill Packaging Ltd

Evaporators Cross Technical Solutions Fisher Scientific Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

Exhibition Design & Display Clip Ltd Ireland

Explosion Proofing Henley Forklift Group Ltd Norgren Ireland Ltd Pilz Ireland Sartorius Mechatronics Ltd

Engineering Services Axium Process Berkley Group P.J. Boner & Co. Ltd 44

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Explosion Protection / Panels CPI Technology Ltd Henley Forklift Group Ltd Pilz Ireland

G e n e r a l S u pp l i e r s

Irish PharmaChem 2012 Gas Detection

SciChem - Cork SciChem - Dublin

Fire Detection/Prevention/ Protection

Cross Technical Solutions Fisher Scientific H.R. Holfeld (Engineering) Ltd SciChem - Cork SciChem - Dublin

Fisher Scientific

Extruders WrenTech Ltd

Facility Design Callaghan Engineering

Facilities Management Goliath Packaging Systems Ltd Hochtief Facility Management

Filling Equipment Axium Process Fraser Ross Ltd Idex Pump Technologies (Ireland) Ltd Ocon Chemicals Ltd Quitmann O’Neill Packaging Ltd Weber Labelling & Coding WrenTech Ltd

Filters Airpower Axium Process CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd Fraser Ross Ltd Idex Pump Technologies (Ireland) Ltd Norgren Ireland Ltd Ocon Chemicals Ltd WrenTech Ltd

Filtration Airpower Axium Process CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd Norgren Ireland Ltd Ocon Chemicals Ltd

Flow Control Airpower P.J. Boner & Co. Ltd CPI Technology Ltd Endress + Hauser (Ireland) Ltd Enva Ireland Ltd Fisher Scientific Flexachem Manufacturing Ltd Fraser Ross Ltd Idex Pump Technologies (Ireland) Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Tyco Valves & Controls Ireland Ltd

Gauges P.J. Boner & Co. Ltd Fisher Scientific Flexachem Manufacturing Ltd Fraser Ross Ltd Manotherm Ltd Ocon Chemicals Ltd Petrochem Pipeline Supply Ltd

Generators Fisher Scientific

Glassware Fluid Handling CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd Fraser Ross Ltd H.R. Holfeld (Engineering) Ltd Idex Pump Technologies (Ireland) Ltd Norgren Ireland Ltd Ocon Chemicals Ltd Petrochem Pipeline Supply Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Fume Cupboards Dalkia Fisher Scientific Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

Furnaces Fisher Scientific SciChem - Cork SciChem - Dublin.

CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd LanganBach Servces Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

Grinding CPI Technology Ltd Fisher Scientific

Hazardous Waste Disposal/Treatment Enva Ireland Ltd Hazchem Training Ltd Idex Pump Technologies (Ireland) Ltd Indaver Ireland Interpac Ocon Chemicals Ltd Quitmann O’Neill Packaging Ltd Soltec (Ireland) Ltd

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Irish PharmaChem 2012 G e n e r a l S u pp l i e r s

Health & Safety/First Aid Fisher Scientific Hazchem Training Ltd Pilz Ireland

Heat Exchangers CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Petrochem Pipeline Supply Ltd ProSys Containment and Sampling Technology

Incineration Enva Ireland Ltd Indaver Ireland Soltec (Ireland) Ltd Tyco Valves & Controls Ireland Ltd

Incubators Fisher Scientific LanganBach Servces Ltd SciChem - Cork SciChem - Dublin Ocon Chemicals Ltd

Allsop Europe Ltd

Ocon Chemicals Ltd

Inspection Equipment Homogenisers Axium Process CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Hoses CPI Technology Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd Henley Forklift Group Ltd Micro Hydraulics Ltd/Micro Industries Ireland

Humidity/Humidifiers Dawsonrentals Irl Ltd Interpac Manotherm Ltd

Hydraulics Bosch Rexroth Ltd Henley Forklift Group Ltd Micro Hydraulics Ltd/Micro Industries Ireland WrenTech Ltd

IDA Ireland

Lab Equipment/Supplies

Injection Moulding Heaters

Investment Promotion Agency

P.J. Boner & Co. Ltd Fisher Scientific Fraser Ross Ltd H.R. Holfeld (Engineering) Ltd Sartorius Mechatronics Ltd

Instrumentation P.J. Boner & Co. Ltd Endress + Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd LABPLAN Manotherm Ltd Norgren Ireland Ltd Ocon Chemicals Ltd Particular Sciences Ltd Petrochem Pipeline Supply Ltd SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd Weber Labelling & Coding

IT GS1 Ireland Premier Validation

Investment

P.J. Boner & Co. Ltd Carbon Group Dalkia Fisher Scientific Flexachem Manufacturing Ltd LABPLAN LanganBach Servces Ltd Ocon Chemicals Ltd O’Flynn Medical Ltd Particular Sciences Ltd ProSys Containment and Sampling Technology Quitmann O’Neill Packaging Ltd Sartorius Mechatronics Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Weber Labelling & Coding WrenTech Ltd

Legal/Financial/ Insurance MacLachlan & Donaldson Matheson Ormsby Prentice

Logistics C+G Logistics Group Chemsource Logistics GS1 Ireland Johnston Logistics Ltd KWE (Ireland) Ltd Movianto Ireland Solv-Echem Ireland Ltd Weber Labelling & Coding

Lifts & Hoists Airpower Goliath Packaging Systems Ltd Henley Forklift Group Ltd WrenTech Ltd

Glanbia Estates Science Foundation Ireland (SFI) 46

42_51 General Suppliers 2012.indd 5

01/06/2012 12:28

Machine Tools Idex Pump Technologies (Ireland) Ltd Lister Machine Tools Ltd Soltec (Ireland) Ltd

Maintenance CPI Technology Ltd Festo Ltd H.R. Holfeld (Engineering) Ltd Goliath Packaging Systems Ltd Particular Sciences Ltd Sartorius Mechatronics Ltd Waters Chromatography Ireland

Medical Device Manufacture B.Braun Medical Croom Precision Medical Ocon Chemicals Ltd

Membrane Filtration Systems

Dawsonrentals Irl Ltd Goliath Packaging Systems Ltd Henley Forklift Group Ltd Interpac Irish Lift Trucks WrenTech Ltd Toyota Material Handling Ireland Ltd

Mechanical Engineering Services Berkley Group Callaghan Engineering CPI Technology Ltd Croom Precision Medical Cross Technical Solutions Dalkia Henley Forklift Group Ltd Goliath Packaging Systems Ltd Pilz Ireland Tyco Valves & Controls Ireland Ltd

Mechanical & Process Engineering Callaghan Engineering CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Pilz Ireland WrenTech Ltd Tyco Valves & Controls Ireland Ltd

Manufacture Portakabin Allspace

microfiltration

Axium Process nanofiltration

Axium Process ultrafiltration

Axium Process

Materials Handling/ Forklifts/Pallet Trucks

Micro Hydraulics Ltd/Micro Industries Ireland Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd WrenTech Ltd

G e n e r a l S u pp l i e r s

Irish PharmaChem 2012

reverse osmosis

Noise/Odour Control Enva Ireland Ltd Flexachem Manufacturing Ltd Ocon Chemicals Ltd

Axium Process

OEM Manufacturing

Meters CPI Technology Ltd Endress + Hauser (Ireland) Ltd Fisher Scientific Flexachem Manufacturing Ltd Manotherm Ltd Ocon Chemicals Ltd Petrochem Pipeline Ltd

Microscopes Fisher Scientific Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin

Milling CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Mixers Axium Process CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd

Axium Process B.Braun Medical Idex Pump Technologies (Ireland) Ltd Medisize Ireland Ltd Tyco Valves & Controls Ireland Ltd

Packaging/Design Anecto Catalent Pharma Solutions Chesapeake Complas Packaging Ltd GS1 Ireland Industrial Packaging Ltd Interpac Measom Freer Millmount Healthcare NPP Group Ltd PrimePac Ltd Quitmann O’Neill Packaging Ltd Smurfit Kappa Ireland Weber Labelling & Coding

Packaging/Machinery B.Braun Medical Chesapeake Goliath Packaging Systems Ltd Interpac Millmount Healthcare NPP Group Ltd Quitmann O’Neill Packaging Ltd Smurfit Kappa Ireland

47

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30/05/2012 17:02

Irish PharmaChem 2012 G e n e r a l S u pp l i e r s

Weber Labelling & Coding WrenTech Ltd

Pallets C+G Logistics Group Complas Packaging Ltd Goliath Packaging Systems Ltd Henley Forklift Group Ltd Interpac Quitmann O’Neill Packaging Ltd WrenTech Ltd

Pharmaceutical Fabrication Axium Process B.Braun Medical Catalent Pharma Solutions Tyco Valves & Controls Ireland Ltd

Pipes/Cores CPI Technology Ltd Flexachem Manufacturing Ltd Petrochem Pipeline Supply Ltd Smurfit Kappa Ireland

Plastic Containers B.Braun Medical Carbon Group Chesapeake CPI Technology Ltd Fisher Scientific Industrial Packaging Ltd Measom Freer Medisize Ireland Ltd Micro Hydraulics Ltd/Micro Industries Ireland Ocon Chemicals Ltd PrimePac Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Plastic Cores / Tubes LanganBach Servces Ltd Smurfit Kappa Ireland

Pneumatics

Pressure Vessels

Airpower Bosch Rexroth Ltd P.J. Boner & Co. Ltd Flexachem Manufacturing Ltd Norgren Ireland Ltd

Pollution Control Enva Ireland Ltd

Powder Handling Carbon Group CPI Technology Ltd Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd Idex Pump Technologies (Ireland) Ltd Norgren Ireland Ltd Ocon Chemicals Ltd ProSys Containment and Sampling Technology Quitmann O’Neill Packaging Ltd Tyco Valves & Controls Ireland Ltd WrenTech Ltd

Pressure Measurements/ Switches/Vessels Airpower Axium Process P.J. Boner & Co. Ltd BS&B Safety Systems Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd

Pressure Relief Airpower BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Pilz Ireland Tyco Valves & Controls Ireland Ltd

Airpower Axium Process BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd Graham Hart (Process Technology) Ltd H.R. Holfeld (Engineering) Ltd Petrochem Pipeline Supply Ltd Tyco Valves & Controls Ireland Ltd WrenTech Ltd

Print Packaging Contego Packaging Group Healthcare

Process Control P.J. Boner & Co. Ltd Callaghan Engineering Endress + Hauser (Ireland) Ltd Fraser Ross Ltd H.R. Holfeld (Engineering) Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Pilz Ireland Sartorius Mechatronics Ltd Tyco Valves & Controls Ireland Ltd Weber Labelling & Coding

Process Design Axium Process Callaghan Engineering Pilz Ireland Weber Labelling & Coding Tyco Valves & Controls Ireland Ltd

Process & Mechanical Engineering Contractors Pilz Ireland Tyco Valves & Controls Ireland Ltd

Project Management Axium Process Callaghan Engineering Glanbia Estates

48

42_51 General Suppliers 2012.indd 7

30/05/2012 17:02

Goliath Packaging Systems Ltd GS1 Ireland Pilz Ireland Premier Validation

CPL Science & Engineering ICDS Recruitment Consultants Lancaster Laboratories Matheson Ormsby Prentice

Protective Clothing/ Apparatus

Refrigeration/Freezing

Fisher Scientific

Pumps CPI Technology Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd H.R. Holfeld (Engineering) Ltd Idex Pump Technologies (Ireland) Ltd Micro Hydraulics Ltd/Micro Industries Ireland Ocon Chemicals Ltd ProSys Containment and Sampling Technology Waters Chromatography Ireland

Quality & Compliance McGee Pharma International

R&D Lancaster Laboratories Medisize Ireland Ltd Ocon Chemicals Ltd PPD Inc. Quintiles Ireland Ltd SciChem - Cork SciChem - Dublin Topchem Pharmaceuticals Ltd Tyco Valves & Controls Ireland Ltd WrenTech Ltd

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

Cross Technical Solutions CRS Mobile Cold Storage Dalkia Dawsonrentals Irl Ltd Fisher Scientific LanganBach Servces Ltd SciChem - Cork SciChem - Dublin

Renewable Energy Dalkia Indaver Ireland Sustainable Energy Authority of Ireland

Robotics ABB Ltd LABPLAN

Sanitary Tubing CPI Technology Ltd Flexachem Manufacturing Ltd Micro Hydraulics Ltd/Micro Industries Ireland Petrochem Pipeline Supply Ltd

SCADA/DCS/MIS P.J. Boner & Co. Ltd

Scrubbers Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

Recruitment

Seals & Gaskets Flexachem Manufacturing Ltd Micro Hydraulics Ltd/Micro Industries Ireland Quitmann O’Neill Packaging Ltd Tyco Valves & Controls Ireland Ltd

G e n e r a l S u pp l i e r s

Irish PharmaChem 2012

Sieving Fisher Scientific Ocon Chemicals Ltd Particular Sciences Ltd WrenTech Ltd

Software Sartorius Mechatronics Ltd Weber Labelling & Coding

Solvent Recovery/ Services Associated Chemicals Ltd Carbon Group CPI Technology Ltd Enva Ireland Ltd Flexachem Manufacturing Ltd Indaver Ireland Ocon Chemicals Ltd Soltec (Ireland) Ltd

Stainless Steel/ Fittings/Products CPI Technology Ltd Cross Technical Solutions Festo Ltd Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd Interpac Micro Hydraulics Ltd/Micro Industries Ireland Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Quitmann O’Neill Packaging Ltd Tyco Valves & Controls Ireland Ltd

Steam Equipment

Berkley Group Brightwater

CPI Technology Ltd Flexachem Manufacturing Ltd 49

42_51 General Suppliers 2012.indd 8

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Irish PharmaChem 2012 G e n e r a l S u pp l i e r s

Fraser Ross Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Tyco Valves & Controls Ireland Ltd

Storage/Bunding C+G Logistics Group CRS Mobile Cold Storage Dawsonrentals Irl Ltd Interpac SciChem - Cork SciChem - Dublin WrenTech Ltd

Fraser Ross Ltd Manotherm Ltd Movianto Ireland Petrochem Pipeline Supply Ltd TeDaC Ltd Tyco Valves & Controls Ireland Ltd

Testing Services Anecto P.J. Boner & Co. Ltd CPI Technology Ltd Fisher Scientific Irish National Accreditation Board Lancaster Laboratories PPD Inc. Waters Chromatography Ireland

Supply Chain Management Catalent Pharma Solutions C+G Logistics Group Chesapeake GS1 Ireland Johnston Logistics Ltd KWE (Ireland) Ltd Movianto Ireland Solv-Echem Ireland Ltd

Thermal Imaging/ Thermography

Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd WrenTech Ltd

Tanks Axium Process Celtic Forwarding Ltd Complas Packaging Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Fraser Ross Ltd Quitmann O’Neill Packaging Ltd WrenTech Ltd

Temperature Control P.J. Boner & Co. Ltd Callaghan Engineering Dawsonrentals Irl Ltd Endress + Hauser (Ireland) Ltd Fisher Scientific Flexachem Manufacturing Ltd

Valves Airpower Axium Process CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd Fraser Ross Ltd Manotherm Ltd Micro Hydraulics Ltd/Micro Industries Ireland Norgren Ireland Ltd Petrochem Pipeline Supply Ltd ProSys Containment and Sampling Technology Tyco Valves & Controls Ireland Ltd WrenTech

Validation

Dalkia Manotherm Ltd

Tools Airpower

Tableting Equipment

Ocon Chemicals Ltd WrenTech Ltd

Transport & Logistics C+G Logistics Group Celtic Forwarding Ltd Chemsource Logistics Hazchem Training Ltd Irish Lift Trucks Johnston Logistics Ltd KWE (Ireland) Ltd Movianto Ireland Quitmann O’Neill Packaging Ltd

Tube Sets/Disposables Fisher Scientific LanganBach Servces Ltd Micro Hydraulics Ltd/Micro Industries Ireland

Vacuum Systems Airpower CPI Technology Ltd Fisher Scientific Flexachem Manufacturing Ltd

Ann McGee Consulting Ltd Callaghan Engineering Cross Technical Solutions Fisher Scientific GS1 Ireland LABPLAN Lancaster Laboratories Pilz Ireland PPD Inc. Premier Validation WrenTech

Ventilation Callaghan Engineering Cross Technical Solutions

Vision Systems Airpower Lister Machine Tools Ltd Weber Labelling & Coding

Warehouse Management Celtic Forwarding Ltd Chemsource Logistics Complas Packaging Ltd Goliath Packaging Systems Ltd

50

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Irish PharmaChem 2012 G e n e r a l S u pp l i e r s

GS1 Ireland Johnston Logistics Ltd Movianto Ireland Solv-Echem Ireland Ltd

Washing Equipment Goliath Packaging Systems Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Waste Management/ Balers/Recycling Goliath Packaging Systems Ltd Idex Pump Technologies (Ireland) Ltd Indaver Ireland Interpac Ocon Chemicals Ltd Quitmann O’Neill Packaging Ltd

Water Treatment ABB Ltd Associated Chemicals Ltd Carbon Group Fisher Scientific Flexachem Manufacturing Ltd

Fraser Ross Ltd Norgren Ireland Ltd Ocon Chemicals Ltd Solv-Echem Ireland Ltd Tyco Valves & Controls Ireland Ltd

Weighing P.J. Boner & Co. Ltd Fisher Scientific Goliath Packaging Systems Ltd Ocon Chemicals Ltd Sartorius Mechatronics Ltd SciChem - Cork SciChem - Dublin Weber Labelling & Coding WrenTech Ltd

Erecting

Inverting

Case Packing

Palletising

Bag-in-Box

Wrapping

Sealing

Strapping

Conveying

AGV Transport

Lifting

Washing Systems

sales installation service

T/F: 067 37893 087 1222816 info@goliath.ie www.goliath.ie BEECHWOOD, NENAGH, CO. TIPPERARY

51

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Irish PharmaChem 2012

Company Listings

Company Listings A

B

Abb Ltd

Address:

Tel: Fax: Email: Web: Business:

Belgard Road, Tallaght, Dublin 24.

(01) 405 7300 (01) 405 7327 marketing@ie.abb.com www.abb.com Lifescience solutions.

Allsop Europe Ltd

Address:

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

Industrial Park, Waterford.

353 51 355091 353 51 377717 noel.kinsella@allsop.eu www.allsopmould.ie Injection moulding products.

Manufacturing & Quality Manager Noel Kinsella.

Tel: Fax: Email: Web: Business:

Mervue Business Park, Co. Galway.

(091) 757 404 (091) 757 387 sales@anecto.com www.anecto.com Dangerous goods packaging testing laboratory.

Associated Chemicals Ltd Address:

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

Address:

3 Naas Road

Industrial Park, Dublin 12.

Tel: (01) 709 1801 Fax: (01) 709 1889 Email: bill.proctor@bbraun.com Web: www.bbraun.com Business: OEM manufacturing.

Contact: Business Unit

Manager: Bill Proctor

Address:

Tel: Fax: Email: Web: Business:

Contact:

Anecto

Address:

B. Braun Medical

P.J. Boner & Co. Ltd Instrument & Weighing Specialists

16D Euro Business Park, Little Island, Co. Cork.

(021) 435 1014 (021) 435 1015 info@acl.ie www.acl.ie Chemical Supplies Managing Director: Sylvester Cotter.

Axium Process Address:

Hendy Industrial Estate, Hendy, Swansea,

SA4 0XP. Tel: (0044) 1792 883882 Fax: (0044) 1792 886049 Email: info@axiumprocess.com Web: www.axiumprocess.com

Berkley Group

Address: Dublin:

509 The Capel

Building,

Mary’s Abbey,

Dublin 7.

Cork:

Mill House,

Carrigrohane,

Co. Cork.

Tel: (01) 872 4666

(021) 428 9600 Email: jhouston@berkley-group.com Web: www.berkley-group.com Contact: Joanna Houston

Betco Marketing Ltd

Tel: Fax: Email: Web: Business:

Contact:

Address:

Tel: Fax: Email: Web: Contact:

Exham House, The Fingerpost, Douglas, Co. Cork.

(021) 436 4999 (021) 436 5739 dhalpin@betco.ie www.betco.ie Managing Director: Diarmuid Halpin

35 Western Parkway Business Centre, Ballymount Drive, Ballymount, Dublin 12.

(01) 450 5050 (01) 450 5183 info@pjboner.com www.pjboner.com Instrument & weighing specialists.

Calibrations.

Managing Director: Patrick Michael Boner Business Development Executive: Leonard O’Sullivan Internal Sales Engineer: Thomas McDonnell

Bosch Rexroth Ltd Address:

Unit 6, Lismard Business Park, Timahoe Road, Portlaoise, Co Laois.

(057) 867 8200 (057) 867 8201 info@boschrexroth.ie www.boschrexroth.ie Engineering company providing drives and controls, linear motion and assembly technology, pneumatics and hydraulics.

Regional Sales Manager: John Doran

52

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01/06/2012 12:32

Brenntag Ireland

Address: Unit 405,

Greenogue Business

Park, Rathcoole,

Dublin 24.

Tel: (01) 401 3500 Fax: (01) 405 3501 Email: dublin.sales@brenntag.ie Web: www.brenntag.ie Contact: Sales Desk

Brightwater

Address: 36 Merrion Square,

Dublin 2.

Tel: (01) 662 1000 Fax: (01) 662 3900 Email: e.moloney@brightwater.ie Web: www.brightwater.ie Contact: Eileen Moloney

BS&B Safety Systems Ltd Address:

Tel:

Fax: Email: Web: Business: Contact:

Raheen Business Park, Raheen, Co. Limerick.

(061) 484 700 Emergency Delivery: 086 241 0615 Direct Line: 086 838 5556 (061) 352 240 sales@bsb.ie www.bsb.ie Pressure relief devices.

Sales Manager: Patrick Murphy

Callaghan Engineering

Tel: Fax:

Camida Ltd

Address:

Tel: Fax: Email: Web: Contact:

Dublin: Wentworth House, 19/20 Hogan Place, Lower Grand Canal St, Dublin 2.

(01) 661 4420 (01) 661 4424 Cork: Suite 257,

52,63 Company Listings 2012.indd 2

Tower House, New Quay, Clonmel, Co. Tipperary.

(052) 612 5455 (052) 612 5466 info@camida.com www.camida.com Company Secretary: Deirdre McGrath

Carbon Group Address: Factory Cross,

Ringaskiddy,

Co. Cork.

Tel: +353 (0)21 437 8988 Mobile: 086 2612 485 Fax: +353 (0)21 437 8950 Email: carol.deegan@carbon.ie sales@carbon.ie Web: www.carbon.ie Business: Pharmachemicals.

Contact: Area Sales Manager:

Carol Deegan

Catalent Pharma Solutions Address:

C Address:

Tel: Fax: Email: Web: Business:

Building 1000, Units 1201& 1202, City Gate, Mahon, Cork.

(021) 240 9099 (021) 240 9009 mail@calleng.ie www.calleng.ie Multi-discipline consulting engineering and project managment company.

Unit 26, Cherry Orchard Industrial Estate,

Dublin 10.

Tel: (01) 620 0600 Fax: (01) 626 2815 Email: diarmuid.wilson@catalent.com Web: www.catalent.com Business: Contract manufactuing

capabilities as well as

packaging and printed

components to the pharmaceutical

industry.

53

Contact:

Director of Business Development: Diarmuid Wilson

Celtic Forwarding Ltd Address:

Tel:

Fax:

Email: Web: Business: Contact:

Dublin: Celtic House, 30 Marlborough Street, Dublin 1.

Waterford: Belview Port, Slieverue, Co. Waterford.

(01) 865 6000 (051) 851 821 (01) 874 6745 (051) 851 823 info@celticfwd.ie www.celticfwd.ie Shipping.

Director: Finbarr Cleary Sales Manager: Gerald Kiernan DGSA Tank Division Manager: Patty deCourcey

Company Listings

Irish PharmaChem 2012

C + G Logistics Group Address:

Tel: Fax: Email: Web: Contact:

Westpoint Business Park, Navan Road, Mulhuddart, Dublin 15.

(01) 820 8455 (01) 820 8457 info@cglogistics.ie www.cglogistics.ie General Manager/ Director: Patrick Wogan Business Development Manager: Cormac Sarsfield

30/05/2012 16:57

Irish PharmaChem 2012 Company Listings

Chemco Ireland Ltd. Address:

Unit 2, Stadium Business Park, Ballycoolin Road, Cappagh,

Dublin 11.

Tel: (01) 829 3600 Fax: (01) 885 5029 Email: sales@chemco.ie Web: www.chemco.ie Business: Chemical

Distribution.

Contact: Sales Director: Peter Fitzgerald

Fax: Email:

(0044) 2890 804 301 sales.pharma@ chesapeakecorp.com Web: www.chesapeake.com/pharma Business: Pharmaceutical and healthcare packaging

(cartons, labels,

leaflets and more).

Complas Packaging Ltd Address:

Tel: Fax: Email: Web:

Naas Industrial Estate, Dublin Road, Naas, Co. Kildare.

(045) 874 088/9 (045) 874 090 sales@complas.ie www.complas.ie

Web: www.corcoranchemicals.com Business: Distribution.

Contact: Sales Department

CPI Technology Ltd 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

Clip Ltd Ireland

Chemsource Industrial Division Address:

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

Unit 2, Stadium Business Park, Ballycoolin Road, Cappagh, Dublin 11.

(01) 882 9117 (01) 885 5029 info@chemsource.ie www.chemsource.ie Chemical Distributors.

Director: John Farrell

Chemsource Logistics

Address:

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

Unit 2, Stadium Business Park, Ballycoolin Road, Cappagh, Dublin 11.

(01) 885 3977 (01) 885 3978 info@chemsource.ie www.chemsource.ie Warehousing,

transport & logistics Director: Sandy McConnachie

Chesapeake Address:

Tel:

Enterprise Way, Hightown Industrial Estate, Newtownabbey, Belfast, BT36 4EW. (0044) 2890 804 000

52,63 Company Listings 2012.indd 3

Address:

First Floor, Cillin Hill,

Dublin Road, Kilkenny.

Tel: (086) 828 3620 Email: paul.smith@clipdisplay.ie www.clipdisplay.ie Web: Business: Exhibition and display equipment manufacture and service.

Irish Sales Manager: Contact: Paul Smith

Contego Packaging Group 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 Ltd

CPL Science & Engineering Address:

83 Merrion Square South, Dublin 2.

Tel: (01) 614 6000 /

(01) 614 6132 Fax: (01) 614 7274 Email: Judith.Moffett@cpl.ie Web: www.cpl.ie Business: Recruitment.

Contact: Science & Engineering

Manager:

Judith Moffett

Croom Precision Medical

Address: Enterprise Centre,

Croom,

Co. Limerick.

Tel: (061) 397 744 Fax: (061) 397 639 Email: info@croomprecision.ie Web: www.croomprecision.com Business: Medical device

manufacture.

Contact: Managing Director:

Patrick Byrnes

Address:

Kingsbridge House, 17-22 Parkgate Street, Dublin 8.

Tel: (01) 633 0400 Fax: (01) 679 3521 Email: info@corcoranchemicals.com 54

30/05/2012 16:57

Eurolec Instrumentation Ltd Cross Technical Solutions

Address:

Unit 26, Second Avenue, Cookstown Industrial Estate,

Cookstown, Tallaght,

Dublin 24.

Tel: (01) 405 6777 Fax: (01) 413 6932 Email: jmcgrath@cross

technicalsolutions.ie Web: www.crosstechnicalsolutions.ie Business: Refrigeration.

Contact: Technical Director:

Jonathan McGrath

General Manager:

Jason Keating

CRS Mobile Cold Storage Address:

Tel: Fax: Email: Web: Business:

Contact:

Arctic House,

Carnisle, Kildalkey, Co. Meath.

(046) 943 5000 (046) 943 5068 enquiry@crs.ie www.crs.ie Cold storage,

pharmaceutical storage, bespoke refrigeration John Tyrell

Dalkia

Address:

Unit 20 Tougher Business Park, Newhall, Naas,

Co. Kildare.

Tel: (045) 448 810 Fax: (045) 448 811 Email: aidanmccauley@eircom.net Web: www.dawsonrentalsireland.com Business: Temperature

Control Solutions.

Contact: Director:

Aidan McCauley

145 Lakeview Drive, Airside Business Park, Swords, Co. Dublin.

(01) 870 1200 (01) 870 1201 info@dalkia.ie www.dalkia.ie Managing Director: Pat Gilroy Industrial Director Pharmaceutical & Health: Fergus Elebert

Endress + Hauser (Ireland) Ltd

Address: Clane Business Park,

Clane, Co. Kildare.

Tel: (045) 868 615 Fax: (045) 868 182 Email: marketing@ie.endress.com Web: www.ie.endress.com Business: Measurement and

process control

solutions for process

industries.

Contact: Sales Manager:

Brian O’Connell

Enva Ireland Ltd Raffeen Industrial Estate, Ringaskiddy, Co. Cork.

(021) 438 7200 (021) 438 7299 cork@enva.ie www.enva.ie

Environmental Protection Agency Address:

Tel: Fax: Email: Web:

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.

F Festo Ltd Address:

E

Address:

Tel: Fax: Email: Web:

D

Address:

Tel: Fax: Email: Web: Contact:

Dawsonrentals Irl. Ltd

PO Box 3000, Johnstown Castle Estate, Co. Wexford.

(053) 916 0600 (053) 916 0699 info@epa.ie www.epa.ie

Company Listings

Irish PharmaChem 2012

Tel: Fax: Email: Web: Business:

Unit 5, Sandyford Park, Sandyford Industrial Estate, Dublin 18.

(01) 295 4955 (01) 295 5680 sales_ie@festo.com www.festo.com/ie Automation company specialising in factory and process automation.

Fisher Scientific Address:

Suite 4, Plaza 212, Blanchardstown Corporate Park 2, Ballycoolin,

Dublin 15.

Tel: (01) 885 5854 Fax: (01) 899 1855 Email: fsie.sales@thermofisher.com Web: www.ie.fishersci.com Business: Laboratory

supplies.

Contact: Marketing

Manager:

Gerry Fitzmaurice

Flexachem Manufacturing Ltd Address:

Tel:

Fax:

Donnybrook Commercial Centre, Douglas, Co. Cork.

(021) 461 7200 / (021) 461 7209 (021) 489 1297

55

52,63 Company Listings 2012.indd 4

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Irish PharmaChem 2012 Company Listings

Email: sales@flexachem.com tim.quigley@flexachem.com Web: www.flexachem.com Business: Manufacturer/

Distributor.

Contact: Operations Manager:

Tim Quigley

Fraser Ross Ltd Address:

Tel: Fax: Email: Web: Business:

Contact:

Castlefort House, Moyvannion, Athlone, Co. Roscommon.

(090) 648 9451 (090) 648 9450 fraserross@eircom.net www.fraserross.ie Fluid handling system specialists. Suppliers of pumps, valves, instrumentation, pipeline products.

Director: Ivan Merrick

Goulding Chemicals Ltd

Address:

Tel: Fax: Email: Web: Business:

Centre Park Road, Marina, Cork City.

(021) 491 1611 (021) 491 1660 kellyt@gouldings.ie www.gouldings.ie Chemical distributor.

Graham Hart (Process Technology) Ltd Address:

Tel: Fax: Email: Web: Contact:

Friars Ind. Estate, Bradford Road, Idle, Bradford, BD10 8SW, UK. (0044) 1274 617021 (0044) 1274 618614 sales@graham-hart.com www.graham-hart.com Sales Director: Stephen Hart

Henley Forklift Group Ltd

Address:

Tel: Fax: Email:

Web: Business:

Contact:

Henley Industrial Park, Killeen Road, Dublin 10.

(01) 620 9200 (01) 626 5406 fwilson@henley.ie phammett@henley.ie www.henley.ie Forklifts &

Warehousing

Equipment.

Specialists in flameproof forklift trucks.

Director: Mark Kenny Director: Brian O’Connell

G GS1 Ireland Address:

Glanbia Estates

Address: Glanbia House,

Ring Road,

Co. Kilkenny.

Tel: +353 (0) 87 256 4339 Email: gmullally@glanbia.com Web: www.kilmeadenfields.com Business: Property Business

Unit of Glanbia PLC. Contact: CEO: Ger Mullally

Goliath Packaging Systems Ltd Address:

Tel: Fax: Email: Web: Business:

Contact:

Beechwood, Nenagh, Co. Tipperary.

(067) 37893 (067) 34794 info@goliath.ie www.goliath.ie Supply & installation of packaging equipment, industrial washing systems, materials handling systems.

Director: George O’Leary

52,63 Company Listings 2012.indd 5

Tel: Fax: Email: Web: Contact:

The Merrion Centre, Nutley Lane, Dublin 4.

(01) 208 0660 (01) 208 0670 info@gs1ie.org www.gs1ie.org Member Support Services: Karen Murphy CEO: Mike Byrne Healthcare Sector Director: Siobhain Duggan

H Hazchem Training Ltd

Address:

Tel: Fax: Email: Web: Contact:

G10, Maynooth Business Campus, Maynooth, Co. Kildare.

(01) 629 1800 (01) 629 1822 info@hazchem.ie www.hazchem.ie Director: Michelle Cleere 56

Heterochem Dist Ltd Address:

Tel: Fax: Email: Business: Contact:

Unit 49, Baldoyle Industrial Estate, Dubllin 13.

(01) 839 3127 (01) 832 5746 kim@heterochem.ie Chemical Distributors Managing Director: Kim Doran

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.

Contact: Region Operations Manager: Ray Casey

30/05/2012 16:57

Company Listings

Irish PharmaChem 2012 H.R. Holfeld (Engineering) Ltd Address:

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

2-4 Merville Road, Stillorgan, Co. Dublin.

(01) 288 7361 (01) 288 7380 pumps@holfeld.ie www.holfeld.ie Process Pump Business: Supplier.

Business Development & Key Accounts: Emmet Connelly

HRB Clinical Research Facility Address:

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

NUI Galway, Geata an Eolais, University Road, Galway.

(091) 495 892 (091) 585 852 lisa.daly@nuigalway.ie www.crfg.ie Clinical Research Programme Manager: Lisa Daly

I ICDS Recruitment Consultants Address:

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

24 Upper Fitzwilliam Street, Dublin 2.

(01) 632 1200 (01) 676 2079 info@icds.ie www.icds.ie Recruitment consultants.

Recruitment Director: Anthony McLoughlin

Idex Pump Technologies (Ireland) Ltd Address:

R79, Shannon Industrial Estate, Shannon, Co. Clare.

Tel: (061) 471 933 Fax: (061) 475 046 Email: coconnell@idexcorp.com cocallaghan@idexcorp.com Web: www.blagdonpump.com

www.vikingpump.com Contact: Customer Services:

Claire O’Connell

Carmel O’Callaghan

Address:

Killarney Road, Bray, Co. Wicklow.

Tel: (01) 286 4010 Email: mail@industrialpackaging.ie Web: www.industrialpackaging.ie Business: Manufacturer of

fibre drums.

Contact: Business Development:

Rob Lee

Interpac Address:

Indaver Ireland

Address:

Tel: Fax: Email: Web: Business:

4th Floor, Block 1, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co. Dublin.

(01) 280 4534 (01) 280 7865 info@indaver.ie www.indaver.ie Hazardous & non- hazardous waste disposal and recovery ensuring full compliance.

Tel: Email: Web: Business: Contact:

67E Heather Road, Sandyford Industrial Estate, Dublin 18.

(01) 294 0600 ian@interpac.ie www.interpac.ie Packaging.

Managing Director: Ian Sutton

Invest Northern Ireland 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.

Irish Exporters Association Life Sciences Ireland Address:

Tel: Fax: Email:

Web: Business:

IDA Ireland

Address:

Tel: Email: Web: Business:

Industrial Packaging Ltd

Wilton Park House, Wilton Place, Dublin 2.

(01) 603 4000 idaireland@ida.ie www.idaireland.com Investment promotion agency.

28 Merrion Square, Dublin 2.

(01) 661 2182 (01) 661 2315 raulmolina@ irishexporters.org www.irishexporters.org Life Sciences

Ireland is Industry Grouping within the Irish Exporters Association.

57

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Irish PharmaChem 2012 Company Listings

Irish Lift Trucks Address: Clonlara Avenue,

Tel: Fax: Email: Web: Business:

Contact:

Baldonnell Business Park, Baldonnell, Dublin 22.

(01) 403 4100 (01) 403 4183 info@irishlifttrucks.ie www.irishlifttrucks.ie Materials Handling Equipment / Hyster Forklifts / Lancer Sideloaders General Manager: Conal McCourt

Irish National Accreditation Board, The Address:

Tel: Fax: Email: Web: Business:

Contact:

Wilton Park House, Wilton Place, Dublin 2.

(01) 607 3003 (01) 607 3109 inab@inab.ie www.inab.ie Provides accreditation of laboratories, certification & inspection bodies.

Information Officer: Orla Doyle

Web: Business:

Johnston Logistics Ltd

Address: Blackchurch Business

Park, Rathcoole,

Co. Dublin.

Tel: + 353 1 401 3333 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

K

J Java Clinical Research Ltd Address:

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

Fitzwilliam Buiness Centre, 26 Upper Pembroke St, Dublin 2.

01 637 3903 01 637 3907 info@javacr.com www.javacr.com Clinical Research Managing Director: Ruth Nallen

Tel:

Fax:

Email:

Web: Contact:

Dublin: Unit 4 Horizon Logistics Park, New Naul Rd, Harristown,

Swords, Co. Dublin.

Cork: Unit 4&5, South Ring West Business Pk, Tramore Road, Co. Cork.

(01) 823 9600 (021) 497 5722 (01) 836 1111 (021) 497 5727 kwedub@ea.kwe.com kweork@ea.kwe.com www.kwe.com Sales Manager: Karl O’Reilly

L LABPLAN

Address:

Tel: Fax: Email:

52,63 Company Listings 2012.indd 7

LanganBach Services Ltd

Address:

Tel: Fax: Email: Web: Business:

Contact:

KWE (Ireland) Ltd Address:

Contact:

Allenwood Business Park, Allenwood, Naas, Co. Kildare.

(045) 870 560 (045) 870 811 info@labplan.ie 58

www.labplan.ie Laboratory supplier to pharmaceutical businesses.

Managing Director: Aidan Smyth 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

Lancaster Laboratories

Address:

IDA Business Park, Clogherane,

Dungarvan,

Co. Waterford.

Tel: (058) 48 300 Fax: (058) 42 855 Email: info@lancasterlabs.com Web: www.lancasterlabspharm.com Business: Contract Analytical Services Contact: Business Development

Director:

Mark Glass

Lennox Laboratory Supplies Ltd

Address:

Tel: Fax: Email:

Web: Business:

John F. Kennedy Drive, Naas Road, Dublin 12.

(01) 455 2201 (01) 450 7906 sales@lennox.ie greg@lennox.ie www.lennox.ie Laboratory suppliers.

30/05/2012 16:57

Lister Machine Tools Ltd

Measom Freer

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: Sale of machine tools & associated equipment.

37-41 Chartwell Drive, Wigston, Leicester, LE18 2FL, UK. Tel: (0044) 1162 881588 Fax: (0044) 1162 813000 Email: sales@measomfreer.co.uk Web: www.measomfreer.co.uk Business: Manufacturer.

Contact: Sales Director: Mark Freer

Address:

Medisize Ireland Ltd

M MacLachlan & Donaldson

Address:

Tel: Fax: Email: Web: Business:

Contact:

47 Merrion Square, Dublin 2.

(01) 676 3465 (01) 661 2083 mail@maclachlan.ie www.maclachlan.ie Intellectual Property Attorneys.

Dr. YvonneMcKeown

Matheson Ormsby Prentice

Address:

Tel: Fax: Web: Business:

70 Sir John Rogerson’s Quay, Dublin 2.

(01) 232 2000 (01) 232 3333 www.mop.ie Law firm.

McGee Pharma International Address:

Tel: Fax: Email: Web: Business:

Address:

Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin.

(01) 846 4742 (01) 846 4898 info@mcgeepharma.com www.mcgeepharma.com Pharmaceutical Quality, Compliance, Technical and Training Specialists.

Address:

Tel: Email: Web: Business:

Contact:

High Road, Letterkenny, Co. Donegal.

(074) 918 8549 info@medisize.com www.medisize.com Contract manufacturer of primary pharmaceutical packaging and medical and diagnostic devices.

Business Development Manager: Marie Nelis

Millmount Healthcare

Address: Block 7, CityNorth

Business Campus,

Stamullen,

Co. Meath.

Tel: (01) 841 8300 Fax: (01) 841 8039 Email: info@millmount.com Web: www.millmounthealthcare.ie Business: Full-service

contract packaging service provider for the pharmaceutical

industry. Fully licensed for primary /

secondary packaging, warehousing and EU batch releases.

Contact: Managing Director:

Pascal Keogh

Company Listings

Irish PharmaChem 2012

Movianto Ireland

Address:

Micro Hydraulics Ltd/ Micro Industries Ireland Address:

Dublin: 2003 Orchard Avenue, Citywest Business Campus, Dublin 24.

Tel: (01) 463 9100 Fax: (01) 410 5609

Cork:

Unit 6/7 Cherrywood Business Park,

Little Island, Co. Cork.

Tel: (021) 451 0570 Fax: (021) 451 0572 Email: info@microhydraulics.ie Web: www.microhydraulics.ie Business: Sanitary hose, tubing & assemblies, sampling valves / connectors.

Official distributor for Staubli Connectors.

Contact: Sales Representative:

Ralph Fitzsimons

Sales Representative:

Dave O’Donavan

Pharmapark,

Chapelizod,

Dublin 20.

Tel: (01) 630 5305 Fax: (01) 630 5400 Email: james.quinn@movianto.com Business: Movianto is a logistics and distribution service provider, specialising

in the pharmaceutical,

biotechnology and healthcare industries.

Contact: Commerial Director:

James Quinn

N National Chemical Co. Ltd Address:

Tel: Fax: Email: Web: Business:

Contact:

NCC House, 42 Lower Leeson St., Dublin 2.

(01) 613 1400 (01) 634 0132 sales@ncc.ie www.ncc.ie Supply Chain Partner -Life Sciences Industries Sales Director: Christy Smith

59

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Irish PharmaChem 2012 Company Listings

Norgren Ireland Ltd

Address:

Tel: Fax: Email: Web: Business:

Contact:

137 Slaney Close, Dublin Industrial Estate, Glasnevin, Dublin 11.

(01) 830 0288 (01) 830 0082 dublin@norgren.com www.norgren.com Fluid and motion control specialist.

Sales Manager: Paul Shankey

NPP Group Ltd Address:

Tel: Email:

Web: Business: Contact:

Unit 509, Mitchelstown Road, Northwest Business Park, Ballycoolin, Blanchardstown, Dublin 15.

(01) 880 9299 sales@npp.ie bmcmahon@npp.ie www.npp.ie Flexible packaging suppliers & distributors.

Sales Director: Eoin McDonagh

O Ocon Chemicals Ltd

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.com Contact: Managing Director:

Frank Mulcahy

O’Flynn Medical Ltd Address:

Westend, Millstreet, Co. Cork.

Tel: (029) 21 799 Fax: (029) 70 191 Email: info@oflynnmedical.com Web: www.oflynnmedical.com Business: Distributor of Scrubex “Automated

52,63 Company Listings 2012.indd 9

Contact:

Protective Clothing Distributor”.

Managing Director: Tadhg O’Flynn

P

Contact: Business:

Particular Sciences provides sales and technical support in material characterisation in Ireland with techniques like particle sizing, imaging and surface energy.

We represent a small group of specialist companies, leaders in their technologies, including Malvern Instruments, Micromeritics, Biolin, Microfluidics, Formulaction and SMS.

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.

Contact: Director:

Sean Quilty

Petrochem Pipeline Supply Ltd Address:

Cork: Unit 14, Euro

Business Park,

Little Island,

Co. Cork.

Tel: (021) 4351300 Fax: (021) 4351166 Email: sales@petrochem.ie Web: www.petrochem.ie Contact: Sales Manager:

Dave Ahern Address: Dublin:

Europa House

Dunboyne Business Park, Dunboyne,

Co. Meath.

Tel: (01) 802 6020 Fax: (01) 801 5860 Email: noel@petrochem.ie Web: www.petrochem.ie 60

Noel Donnelly, Declan Murphy Supplier of

Stainless Steel Pipes, Fittings, Flanges, Fasteners, Valves, Steam

Products, Instrumentation and Controls to the Irish Pharmaceutical and Biotech markets.

Pilz Ireland Address:

Cork Business & Technology Park, Model Farm Road, Co Cork.

Tel: (021) 434 6535 Fax: (021) 480 4994 Email: sales@pilz.ie Web: www.pilz.ie Business: Process and machinery saftey engineering services and training.

Contact: Sales Manager:

Andrew Donnelly

MD: John McAuliffe

P.K. Chemicals Ltd Address:

Unit 23, Sandyford

Office Park,

Blackthorn Avenue,

Foxrock, Dublin 18.

Tel: (01) 295 6977 Fax: (01) 295 8338 Email: debbie@pkchemicals.com Business: Chemical

Distributor.

Contact: Purchasing and Sales

Manager:

Sarah Murphy

30/05/2012 16:57

S

PrimePac Ltd

Portakabin Allspace

Address: Roseville Business

Park, Turvey Avenue,

Donabate,

Co. Dublin.

Tel: (01) 808 5055 Fax: (01) 808 5150 Email: sales@portakabinallapace.ie Web: www.allspace.ie Business: Modular and portable

buildings supply and

manufacture.

Contact: National Hire

Manager:

Mike Sheedy

PPD, Inc. Address:

Building C, Athlone Business & Technology Park, Garrycastle, Athlone,

Co. Westmeath.

Tel: (0906) 460 300 Fax: (0906) 460 301 Email: susan.neenan@ppdi.com Web: www.ppdi.com Business: Contract Research Organisation.

Contact: Director, GMP Labs, Europe:

Susan Neenan

Premier Validation Address:

Tyone, Nenagh,

Co. Tipperary.

Tel: (01) 443 4016 Email: graham.okeeffe@

premiervalidation.com Web: www.premiervalidation.com Business: Validation and

regulatory compliance

specialists.

Contact: Director of

Operations:

Graham O’Keeffe

Address:

Tel: Fax: Email: Web: Business:

Contact:

Unit 2, Caulside Drive, 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

ProSys Containment And Sampling technology Address:

Tel: Fax: Email: Web:

IDA Business Park, Carrigtohill, Co. Cork.

(021) 485 3900 (021) 485 3866 mmcl@prosys.ie www.prosys.ie

Q 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: St. Brendan’s Road,

Portumna,

Co. Galway.

Tel: (090) 974 1148/9 Fax: (090) 974 1459 Email: sales@quitmannoneill.com Web: www.qonpack.com Business: Packaging stockist & distributors.

Contact: General Manager:

David O’Neill

Sartorius Mechatronics UK Ltd Address:

Unit 41, The Business Centre, Stadium Business Park, Ballycoolin Road, Dublin 11.

Tel: (01) 808 9050 Fax: (01) 808 9388 Email: info.ireland@sartorius.com Web: www.sartorius.ie Business: Laboratory & process technology provider.

Sales & service of laboratory & process weighing equipment.

Contact: Nick Parsons

Company Listings

Irish PharmaChem 2012

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

Science Foundation Ireland (SFI) Address:

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

Wilton Park House, Wilton Place, Dublin 2.

(01) 607 3200 (01) 607 3201 info@sfi.ie www.sfi.ie Government funding agency for research.

Director Enterprise & International Affairs: Dr. Ruth Freeman

61

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Irish PharmaChem 2012 Company Listings

Sustainable Energy Authority of Ireland Smurfit Kappa Ireland

Address:

Tel: Fax: Email: Web:

Business: Contact:

Ballymount Road, Walkinstown, Dublin 12.

(01) 409 0000 (01) 456 4506 info@smurfitkappa.ie www.smurfitkappa.ie www.skpackaging.ie Packaging.

Marketing Manager: Mark Munnelly

Soltec (Ireland) Ltd

Address: Zone A, Mullingar

Business Park,

Mullingar,

Co. Westmeath.

Tel: (044) 933 5133 Email: info@soltec.ie Web: www.soltec.ie Business: Soltec is Ireland’s only commercially operated solvent

recycling plant. Solid

hazardous waste

collections also

provided.

Contact: Business Development

Manager:

Michael Corcoran

Solv-Echem Ireland Ltd

Address: Great Island

Industrial Park,

Ballincollig,

Co. Cork.

Tel: (021) 487 7066 Email: tony@solvechem.com Web: www.solvechem.com Business: Chemical distribution.

chemicals, solvents,

water treatment,

warehousing.

Contact: Director:

Tony Murray

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

T

Address: Victoria House,

Beaumont Avenue,

Churchtown,

Dublin 14.

Tel: (01) 295 1101 Email: tkilbane@tyco-valves.com Web: www.tycoflowcontrol-eu.com Business: Industrial valves & controls.

Contact: General Manager:

Tony Kilbane

U Univar Ltd

TeDaC Ltd Address:

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

31 Cleeve Lodge Road, Downend, Bristol, England, BS16 6AF. 004417 910 4821 0044751 566 0775 info@tedac.co.uk www.tedac.co.uk Temperature and humidity mapping services.

Director: Chris Bell

TopChem Pharmaceuticals Ltd Ballymote Business Park, Carrownanty,

Ballymote,

Co. Sligo.

Tel: (071) 918 9685 Fax: (071) 919 7864 Email: donal@topchempharma.com Web: www.topchempharma.com Business: Development and manufacture of

pharmaceutical active ingredients.

Contact: Managing Director:

Donal Coveney

Address: 536 Grants Crescent,

Greenogue Business

Park, Rathcoole,

Co. Dublin.

Tel: (01) 401 9800 Fax: (01) 401 9142 Email: pharma.sales@

univareurope.com Web: www.univareurope.com Business: Ingredients pharma industry including API’s, excipients, process chems, solvents & intermediates.

Contact: Account Manager:

John McCluskey

Address:

Toyota Material Handling Ireland Ltd

Address:

Tel: Fax: Business: Contact:

52,63 Company Listings 2012.indd 11

Glasnevin, Dublin 9.

(01) 836 9080 (01) 837 2848 info@sei.ie www.sei.ie Energy advice & information.

Tyco Valves & Controls Ireland Limited

Killeen Road, Dublin 12.

(01) 419 0200 (01) 419 0325 Forklift and

Warehouse Supplies.

Terry O’ Reilly 62

W 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.

30/05/2012 16:57

Contact:

National Sales Manager: Davnet Donnelly

Weber Labelling & Coding Address:

Kilcannon Ind. Est., Old Dublin Road, Enniscorthy,

Co. Wexford.

Tel: (053) 923 3778 Fax: (053) 923 3284 Email: sales@weberireland.com Web: www.webermarking.ie Contact: Operations Manager:

Patrick Hughes

WrenTech Ltd

Address:

Tel: Fax: Email: Web: Contact:

Eversley, Church Bay Road, Crosshaven, Co. Cork.

(021) 483 2644 (021) 483 1363 smurray@wrentech.ie www.wrentech.ie Sales Administrator: Siobhan Murray

Zetes Ireland Address:

Tel: Fax: Email: Web: Business:

Contact:

The National Technological Park, Limerick.

(061) 333 188 (061)333 133 sales@ie.zetes.com www.zetes.ie Auto ID software and hardware including barcode label printers, print & apply, hand held computers, serialisation & warehouse inventory solutions.

Business Development Manager: Barry Long

Company Listings

Irish PharmaChem 2012

Notes

63

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I r i s h P h a r m a C h e m 2012

Useful References ACADEMY OF MEDICAL LABORATORY SCIENCE Tel: (01) 677 5602 E-mail: mail@amls.ie Web: www.amls.ie

ENTERPRISE IRELAND Tel: (01) 727 2000 E-mail: client.service@enterprise-ireland.com Web: www.enterprise-ireland.com

Advisory Council for Science, Technology & Innovation Tel: (01) 607 3162 E-mail: firstname.surname@forfas.ie Web: www.sciencecouncil.ie

ENVIRONMENTAL HEALTH OFFICERS’ ASSOCIATION Tel: (01) 276 1211 E-mail: info@ehoa.ie Web: www.ehoa.ie

AN BORD PLEANALA Tel: (01) 858 8100 LoCall: 1890 275 175 E-mail: bord@pleanala.ie Web: www.pleanala.ie CHAMBERS IRELAND Tel: (01) 400 4300 E-mail: info@chambers.ie Web: www.chambers.ie

IRISH BUSINESS & EMPLOYERS CONFEDERATION (IBEC) Tel: (01) 605 1500 E-mail: info@ibec.ie Web: www.ibec.ie

BIOTECHNOLOGY IRELAND Tel: (01) 727 2668 E-mail: editor@biotechnologyireland.com www.biotechnologyireland.com FORFAS Tel: (01) 607 3000 E-mail: firstname.surname@forfas.ie Web: www.forfas.ie

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

HEALTH AND SAFETY AUTHORITY Tel: (01) 614 7000 Lo Call: 1890 289 389 E-mail: wcu@hsa.ie Web: www.hsa.ie

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

HEALTH RESEARCH BOARD Tel: (01) 234 5000 E-mail: hrb@hrb.ie Web: www.hrb.ie

ELECTRICITY SUPPLY BOARD Tel: 1850 372 372 E-mail: esbnetworks@esb.ie Web: www.esb.ie

IRISH BIOINDUSTRY ASSOCIATION Tel: (01) 605 1584 E-mail: firstname.surname@ibec.ie Web: www.ibec.ie/ibia

ENVIRONMENTAL PROTECTION AGENCY Tel: (053) 916 0600 LoCall: 1890 335 599 E-mail: info@epa.ie Web: www.epa.ie

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

DEPT. OF THE ENVIRONMENT, COMMUNITY & LOCAL GOVERNMENT Tel: (01) 888 2000 LoCall: 1890 20 20 21 E-mail: press-office@environ.ie Web: www.environ.ie

INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINERING (ISPE) Tel: +32 2 743 4422 E-mail: ispe@associationhq.org Web: www. ispe.org

IRISH CLEANROOM SOCIETY Tel: (091) 790 693 E-mail: info@cleanrooms-ireland.ie Web: www.cleanrooms-ireland.ie IRISH COSMETICS, DETERGENT & ALLIED PRODUCTS ASSOCIATION Tel: (01) 605 1671 E-mail: icda@ibec.ie Web: www.icda.ie IRISH EXPORTERS ASSOCIATION Tel: (01) 661 2182 E-mail: iea@irishexporters.ie Web: www.irishexporters.ie IRISH MEDICAL DEVICES ASSOCIATION Tel: (01) 605 1564 E-mail: firstname.surname@ibec.ie Web: www.ibec.ie/imda

HIGHER EDUCATION AUTHORITY Tel: (01) 231 7100 E-mail: info@hea.ie Web: www.hea.ie

IRISH MEDICINES BOARD Tel: (01) 676 4971 E-mail: customerservice@imb.ie Web: www.imb.ie

IDA - INDUSTRIAL DEVELOPMENT AGENCY Tel: (01) 603 4000 E-mail: idaireland@ida.ie Web: www.idaireland.com

IRISH NATIONAL ACCREDITATION BOARD Tel: (01) 607 3003 E-mail: info@inab.ie Web: www.inab.ie

INSTITUTE OF CHEMISTRY OF IRELAND E-mail: info@instituteofchemistry.org Web: www.instituteofchemistry.org

IRISH PATENTS OFFICE Tel: (056) 772 0111 E-mail: patlib@patentsoffice.ie Web: www.patentsoffice.ie

IRISH PHARMACY UNION Tel: (01) 493 6401 E-mail: firstname.surname@ipu.ie Web: www.ipu.ie IRISH VENTURE CAPITAL ASSOCIATION Tel: (01) 276 4647 E-mail: secretary@ivca.ie Web: www.ivca.ie INVEST NORTHERN IRELAND Tel: (01) 234 2533 E-mail: eo@investni.com Web: www.investni.com MANDATE TRADE UNION Tel: (01) 874 6321 E-mail: mandate@mandate.ie Web: www.mandate.ie NATIONAL INSTITUTE FOR TRANSPORT & LOGISTICS (NITL) Tel: (01) 402 3000 E-mail: nitl@dit.ie Web: www.nitl.ie PARENTERAL DRUG ASSOCIATION (PDA) Tel: +1 (301) 656 5900 E-mail: info@pda.org Web: www.pda.org Pharmaceutical society of Ireland Tel: (01) 218 4000 E-mail: info@thepsi.ie Web: www.thepsi.ie PHARMACHEMICAL IRELAND Tel: (01) 605 1584 E-mail: pharmachemicalireland@ibec.ie Web: www.pharmachemicalireland.com REPAK Tel: (01) 467 0190 E-mail: info@repak.ie Web: www.repak.ie SCIENCE FOUNDATION IRELAND Tel: (01) 607 3200 E-mail: info@sfi.ie Web: www.sfi.ie

64

64 Useful Refs Relevant Org.indd 1

30/05/2012 17:07

B. Braun OEM Division Connecting Competences. Realizing Ideas.

Products, Project Management and Services for the Healthcare Industry

As one of the leading companies in the healthcare market, B. Braun is your professional and reliable outsourcing partner for pharmaceutical contract manufacturing and customized product variation and combination.

Rely on our expertise in infusion therapy and project management and contact us for your system-built outsourcing solution.

Products Pharmaceutical solutions Medical devices Disinfection & hygiene

Project Managament Product variation and combination Pharmaceutical contract manufacturing

Services Analytical services Regulatory support Customer service

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Berkley ad.indd 1

30/05/2012 13:56