orangeglobal_pharma

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How do you exploit opportunities you do not know are there?

orangeglobal

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orangeglobal Medical Globalisation Provider Multilingual product and corporate communication specialising in medicine + pharma

Pharma Human medicine Dental practice Pharmacology Toxicology Pharmacy Chemistry Laboratory medicine Biology

Biochemistry Biotechnology Nanobiotechnology Microbiology Physics Information technology Marketing

orangeglobal

medical globalisation provider

MARKET RESEARCH

III

Internationalisation and Master Creation

PHARMACOViGILANCE

REGULATORY AFFAIRS

communication science

VII

LANGUAGE, TRANSLATION AND LOCALISATION

VIII

MARKeting support

TECHNOLOGY AND ENGINEERING

contact

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Business model | Service index

International market research

International master creation

III

Risk evaluation for market registration | Risk surveillance

Analysis of international corporate and product communication | Optimisation of international corporate and product communication

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Visualisation of international marketing materials: creative design, implementation and optimisation | Group targeting through international marketing materials | Pre-press

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Software: solutions | Technological support and consulting

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orangeglobal

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I orangeglobal – The market-leading globalisation partner in healthcare orangeglobal offers you the opportunity of support for your healthcare products in all markets around the world What is a globalisation partner?

associated with a product in such a way that they are organised more efficiently: to a high level of quality and, ideally, orangeglobal provides high-quality and reliable supwithin budget limits, in a standardised logistical process. port for healthcare products in international markets. This process provides certainty in each target market. orangeglobal‘s core competence: standardised or individual, one-off or global solutions throughout the product Why is a competent globalisation partner more management cycle. Our unique feature: constant focus on important than ever nowadays? Today about 70% of the total turnover of this sector is geinternationally. In addition, changes in the global The aim is to dovetail the processes nerated economic situation have had major effects on the healthassociated with a product in such a care industry. Innovation and export are taking place not in Western industrial nations and business centres, but way that they are organised more just throughout the world – particularly in Brazil, Russia, India efficiently: to a high level of quality and China the BRIC countries. As a result, international comis intensifying. But, at the same time, economically and, ideally, within budget limits, in petition very interesting markets are opening up in these locations. a standardised logistical process. These need to be accessed with specifically localised, hyperlocally adapted products, as well as with corporate and product communication in the national language. This rethe internationalisation of products and their accompanyquirement can generate uncertainty, a large administrative ing documentation from the outset. The process chain alcommitment and disproportionate internal costs. ways starts with the design or creation of a culture-neutral, internationalised “master“ which we then adapt for the tar- Language is one example: Even in the area of medical secget group or locality. The aim is to dovetail the processes tor, English as the lingua franca can no longer be the uni-

orangeglobal

I versal solution. According to a study by the US company markets offers the potential for optimisation, both within Common Sense Advisory, 98% of the international target the company and in terms of suppliers. Only by consistently group surveyed, which includes the new markets in the including internationalisation in the considerations can you enhance product and communication quality, reduce costs and decrease the time commitment and time-to-market inHow can you develop, license and volved.

market products reliably and specifically to national and local target groups?

Only by consistently including internationalisation in the considerations can you enhance product and communication quality, reduce costs and decrease the time commitment and time-to-market involved.

BRIC countries, prefers a company that offers product communication in their own language. This development is also apparent on the official side: national authorities require product-related documents to be localised and presented in the national language concerned. If a company wants to sell its products internationally, the need for localisation increases. At the same time European companies are losing 100 billion euros annually because of their lack of a foreign language strategy (source: ELAN Studies 2006). Outsourcing individual support tasks from the central company process “International proAccessing new markets and strengthening existing markets duct support“ – fine in theory, but is it effective in pose certain challenges: How can you develop, license and practice? market products reliably and specifically to national and local target groups? How do you organise the international Outsourcing should mean the uncomplicated delegation of paperwork? How do you co-ordinate the consideration of specific tasks to external service providers, who then supspecific national aspects, in the regulatory area, for examp- ply a “market-ready“ product. In reality, contractors often le? have to devote their own administrative efforts to organising correction loops, sometimes transcending departments The logistical chain from product development to global

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I and countries. This can then be referred to as “problem factor outsourcing“, affecting all the stations along the line of the international product management cycle. This situation is due to the natural uncertainty that prevails at every step toward a foreign market. Even the quality assurance

Only through long-term, consistent co-operation with a partner who works in an interdisciplinary and responsible manner can you optimally exploit the benefits of outsourcing – making it once again what it is intended to be: rational, professional and intelligent. and process-oriented standards that service providers use for guidance are not sufficient to guarantee fundamental certainty. Certainty, therefore, comes at a price.

co-operation with a partner who works in an interdisciplinary and responsible manner can you optimally exploit the benefits of outsourcing – making it once again what it is intended to be: rational, professional and intelligent. This requires a willingness on your part, as the contractor, to change ingrained processes.

The orangevillage and the orangeglobal Centres of Competence represent the interdisciplinary pool of resources that can reflect the complexity of the whole sector and its international requirements throughout the product management cycle. How can orangeglobal assume the role of your globalisation partner in every aspect?

The practice of outsourcing then loses its rationale: reduction of fixed costs, use of specialist knowledge and reduced We have 36 years of experience in the international healthorganisational demands. care sector, developing standardised best practices, software-assisted tools and, above all, an interdisciplinary apYet delegation of peripheral competence and focusing on proach: The orangevillage and the orangeglobal Centres your own core competence are more important than ever, of Competence represent the interdisciplinary pool of realbeit in a new form: Only through long-term, consistent

orangeglobal

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I sources that can reflect the complexity of the whole sector and its international requirements throughout the product management cycle: In each country, for each language and culture, and for each specialist area, there is an expert who precisely meets your requirements – whether it‘s for an active visit to the authorities in China or for a translation into an Indian dialect. Right now, the orangevillage numbers several thousand specialists and it is constantly being extended and supplemented.Today, it is the largest worldwide, centrally organised pool of subject experts that specialises in the healthcare sector.

lysis, digital dictionaries, special databases and customer platforms to automate and simplify processes. Technology and software play a vital role in modern, efficient work processes, but can often mean an enormous investment and a major training commitment for a company. orangeglobal owns a number of complex tools in an extensive technology pool. Through the rational pooling of tasks and process stages and the international interaction of disciplines and technologies with regard to international markets, we can achieve the following:

In our internationally organised orangeglobal Centres of • Enhanced quality of product, documentation and Competence, focused know-how is pooled in a similar way processes to the various functions of healthcare company. This includes market research, pharmacovigilance, regulatory affairs, • Reduction or control of the budget share – cost savings communication science, language, translation and localiof up to 30% sation and marketing support to technology and enginee• Reduction of supplier costs ring. • Reduction of administrative work commitment Our specialist, subject-specific and interdisciplinary knowhow is supplemented by the approximately 100-strong • Decisive reduction in time-to-market organisation of the orangeglobal System Centre, from Thanks to the variety of people „behind the scenes“, oranwhich the orangeglobal Centres of Competence also are geglobal is able to offer this extensive range of services controlled. Here you will find the customer contacts and through our orangeglobal globalisation portfolio. If you the necessary functions of scientific consultant and process cannot find the specific service you require or have an inanalyst up to scientific project and liaison manager. We can dividual enquiry about the processes described, then pleresearch, test and where applicable, implement innovaase contact us. We are certainthat orangeglobal (Scientific) tions and first-to-market products for our customer. Business Development can help you find the optimal soluIn addition, we develop new software in the orangeglobal tion for your business needs. System Centre, such as tools for uncomplicated text ana-

orangeglobal

I Essentially, orangeglobal offers different forms of cooperation at a range of quality and cost levels. We would be happy to convince you with an initial trial commission.

... our credo is always: “Working with the customer, not just for him.“ Our credo is always: „Working with the customer, not just for him“, because we believe it is only through long-term co-operation and the gradual establishment of a logistical process that sustained improvements can be achieved.

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orangeglobal

I Wherever your healthcare product may land – we could already have prepared the ground… In whichever market you have an outcome to achieve– orangeglobal is ready, with the necessary expertise on site.

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orangeglobal

I Imagine that a partner, could help you to adapt each product precisely and with state-of-the-art quality to each individual market, launch it simultaneously and at the same time save costs? How soon would you call them? orangeglobal provides high-quality and reliable product support in international markets. Our core competence: standardised or individual, one-off or global solutions throughout the product management cycle. Our unique

feature: a constant focus on the internationalisation of products and the accompanying documentation, as well as the efficient integration of individual tasks, right from the outset.

orangeglobal

I Success factor: outsourcing? Are you co-ordinating a number of individual service providers? Do you have correction loops? How would you like to delegate this time-consuming administration? If you donâ&#x20AC;&#x2DC;t get it right, outsourcing can entail particularly high costs and can be very time-consuming internally. The cause of the problem lies in a natural uncertainty at each step in a foreign country. One-off solutions in the service provision market are time-consuming in their need for individual co-ordination and at the same time do not provide sufficient certainty. This is partly due to the fact that quality assurance standards, such as DIN EN 15038 for translation

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processes, do not meet customer requirements. As a result, each item has to be checked and corrected several times in-house despite the use of service providers â&#x20AC;&#x201C; a time- and cost-intensive process. The solution: an on-going partnership with a service provider who operates on an interdisciplinary basis. Outsourcing then reverts to being what it should be: Rational. Intelligent. Efficient.

orangeglobal

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I Success factor: ’Master’ - If you internationalise the source, your product can be placed more successfully in shorter time than you imagined, in india, for example. One of the basic principles of efficient, internationally ori- considered right at the start of the project, that will save ented workflows is: Success begins with the creation of a you valuable time and money during the future localisation “master“. If the possibility of international application is process by avoiding subsequent correction loops.

orangeglobal

I Success factor: ‘Individuality’ several thousand experts from all areas of the healthcare sector are available to you around the globe. When do you use this potential? Unique people for orangeglobal: The technically highly complex healthcare sector with all its experts is mirrored in the largest specialist pool of its kind in the world, the

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orangevillage – for each area, for each country, for each active and passive task. This is how hyperlocalisation becomes achievable.

orangeglobal

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I The â&#x20AC;&#x2122;Thinkerâ&#x20AC;&#x2122; - if you want to register your product in Brazil, Dr Gabriel de Assis Moreira already has the solution to hand. In the orangevillage, for each relevant specialist field of the healthcare sector, there is an expert like Dr Gabriel de Assis Moreira, who takes over the specialist, strategic, con-

sultancy and linguistic/cultural aspects of the product management cycle.

orangeglobal

I The â&#x20AC;&#x2DC;Walkerâ&#x20AC;&#x2122; - if you ever have to visit the authorities in Moscow, Dr Irina Pavlova is there at your disposal. In the orangevillage there are also specialists like Dr Irina Pavlova who can undertake active tasks on your behalf,

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such as visiting the authorities, on-site specialist meetings, visits, searches, etc.

orangeglobal

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I Success factor: â&#x20AC;&#x2122;Peopleâ&#x20AC;&#x2122; - functions are integrated behind the scenes in the orangeglobal System Centre - which ones would you like to use? Scientific Business Development, Project Management, Software Support, IT Services, Liaison Management...? Integrated internationality: around 100 full-time staff from tific) adviser, project manager and business developer to ten nations are encompassed within the organisation of the the regulatory, technology, marketing and legal experts, orangeglobal System Centre. From here the orangeglo- purchaser and liaison manager. bal Centres of Competence are controlled: from the (scien-

orangeglobal

I The ‘Liaison manager’ - misunderstandings are a thing of the past. Akiko Okamoto, microbiologist and resident in Germany for 15 years, could be your future communication link with your Japanese headquarters. To be able to assume the role of globalisation partner, certain functions must be fulfilled by specialists: these include on the one hand international subject specialists, IT specialists and language and cultural experts, but also, on the

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other, moderators, such as the liaison manager. These act as a central „window“ for communication, control and quality assurance between the internationally involved parties – both internal and external to the customer.

orangeglobal

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I Success factor: â&#x20AC;&#x2DC;Interdisciplinarityâ&#x20AC;&#x2122; - a strong partnership for efficient, holistic product management in sales markets around the globe. orangeglobal must operate on an interdisciplinary basis as a globalisation partner to carry out the highly complex product support tasks involved in the healthcare sector as a whole. For this reason, in addition to the orangevillage, orangeglobal has established the orangeglobal Centres of Competence â&#x20AC;&#x201C; a reflection of the disciplines that are vi-

tally important for efficient logistics. Only by working hand in hand with all the disciplines, experts and their logistical integration is it possible to sustain enhancement of quality, minimise time expenditure and reduce time-to-market and costs.

orangeglobal

I Success factor: ’Co-operation’ - How orangeglobal can support you individually in your area of specialisation. By co-operating with orangeglobal, you can delegate tasks that are currently outsourced to individual service providers to orangeglobal in its role as globalisation partner. By virtue of its interdisciplinary structure, orangeglobal is able to merge tasks from different disciplines, specialist

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areas and aspects of product management. This eliminates time-consuming co-ordination activities and enables processes to be carried out very beneficially and - crucially within your planned budget (see orangeglobal Process Performance).

01. Taking on a single task

02. orangeglobal Process Performance

03. Partnership with orangeglobal

Self-evident: orangeglobal provides a high-quality service that is delivered according to the state of the art and within the timelines. Our scientific business development and project management teams monitor the order and are at your disposal for any questions.

Added value: orangeglobal merges individual services from the orangeglobal portfolio in an interdisciplinary approach. Attention here is focused on the systematic planning of an efficient process that is completed optimally in accordance with the order. With its interdisciplinary structure orangeglobal is able to add value to the product.

“One-Plus-More“ In a long-term, well-structured, well-planned and consistently run partnership, you can rely upon a first-rate result based on jointly defined indicators: cost reduction, enhanced quality, short time-to-market. Your processes interlinked efficiently with the interdisciplinary orangeglobal solutions.

orangeglobal

I How can you „start“ with orangeglobal? orangeglobal invests in co-operation – your first main consumers and decision-makers must participate, workshop is free of charge will involve a discussion of the potential for optimisation, where unnecessary redundancies occur, and how internal Outsourcing must be organised in new ways to fulfil its commitments can be reduced. Preliminary solutions will be original purpose of cost reduction, enhanced quality and proposed.

Try out orangeglobal by gving us individual tasks or process chains. We will be happy to define the scope of a pilot phase together with you in order to form the basis for successful co-operation.

Confidence must be earned – try orangeglobal out for yourself

The workshop is designed to be the first step in the partnership. Partnership requires confidence – and that must be earned. So try out orangeglobal by giving us individual tasks or process chains. We will be happy to define the scope of a pilot phase together with you in order to form the basis for successful co-operation. In this context we also help with budget planning and define preliminary reduced administrative involvement rather than becoming goals and key performance indicators so you can measuan additional burden. Long-term co-operation with an out- re orangeglobal‘s performance. The orangeglobal sersourcing partner focused on systematic targets is the pre- vice platform can be set up at this stage if required. Regurequisite for this. lar, monthly practice vs. theory reports, quality checklists, feedback loops, including from the customer market, and The foundation stone for a partnership of this kind with meetings make orangeglobal‘s work transparent. Costs orangeglobal is laid in a preliminary workshop. A small and time demands can be scheduled, quality visualised team of our experts, defined in advance on the basis of and weaknesses gradually reduced. your requirements, will visit you. The app. 2-hour long workshop, in which the

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orangeglobal

I Beginning of the work in partnership Once the basis has been laid, a partnership can be formulated, to achieve the set aims of cost reduction, enhanced quality and reduced time-to-market - sustainably and permanently. Key performance indicators are defined jointly, processes, resources, timelines, budget planning, monitoring and reporting are planned definitively. Each individual module, each individual resource is organised, co-ordinated and efficiently incorporated into the orangeglobal System Centre.

Success factor: â&#x20AC;&#x2DC;Outcomeâ&#x20AC;&#x2122; - enhanced quality, cost reduction, reduced time-to-market The overriding aims of co-operation with orangeglobal are the three factors that are always promised: enhanced quality, reduced time-to-market and cost reduction. Our constant concern, however, is to achieve these aims sustainably and hence permanently. This is only possible on an interdisciplinary basis, which enables individual tasks from different areas of competence to be integrated into effective workflows. Outsourcing individual tasks to one-off solutions on the market provides only part of the promised benefit and at the very best only temporarily.

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orangeglobal

A year at orangeglobal 457 customer presentations around the globe 118,000 kilometres driven Nearly 203,000 kilometres flown Over 180,000 customer telephone calls Establishment of more than 100 new services More than 4,400,000 words translated Extension of the organisation in the System Centre to include 10 different cultures Granting of 2 â&#x20AC;&#x153;Move Awardsâ&#x20AC;&#x153; for staff who have produced some change in the company In-house development of 5 new software systems Maintenance of more than 725 active customers worldwide Inspection of close to 1400 applications for the orangevillage Inclusion of around 1000 new experts in the orangevillage Recruitment of 6 trainees for the newly established youth development programme 1 successful recertification to DIN EN ISO 9001:2008 More than 900 containers of water and 9500 litres of coffee consumed

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Several thousand customer feedbacks – a sample: “Many thanks to you and your „art-studio“ for the careful and high-quality work!“ (Marketing) “I am pleased that we are so well within the guidelines of the project plan and wish to thank you once again for the constructive assistance.“ (Regulatory Affairs) “Many thanks for the ultrarapid support. As mentioned, I think the questionnaire already works very well.“ (Quality Management) “「本当にありがとうございました。次回のコラボレーションを楽しみにしています。」“ (Medical Advisory) “Would you please give my thanks to the whole team at orangeglobal, especially the project team, medical writers and graphic designers for the immense effort […]. I am very relieved and very grateful that all the logistics have in the end coped with all of our requirements. It has been a pleasure working with you, and I can honestly say that the customer service provided by orangeglobal has been exceptional.” (Regulatory Affairs) “Many thanks for the uncomplicated and rapid handling of our order.“ (Scientific Department) “Many thanks and it really was an excellent and professional job. Translation + interpreter - all to my complete satisfaction.“ (Marketing) “Many thanks for this and for making this such an efficient process.” (Product Development) “We appreciate your gesture and the professional manner in which you have handled the project.” (Lean Six Sigma) “Спешу Вам сообщить, что наш отдел очень доволен Вашей работой, и еще раз хочу Вас поблагодарить за быстрое выполнение нашего заказа.“ (Purchasing) “Many thanks for the very good work you and your colleagues provide.“ (Cost Control) “En toda mi vida profesional no voy a contratar ningún otro proveedor de servicios.“ (Product Management) “Many, many thanks for the prompt revision of the text. It is first rate or (as I put it on the telephone just now): it is really good now and the expressions have the right feel. It‘s really brilliant now.” (Marketing)

orangeglobal

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Multinational clinical trial labelling creation

Seminars: international regulatory affairs

Scientific support: international regulatory affairs

Expert support: international regulatory affairs

Optimisation of international regulatory strategy

Translation: pharmacovigilance translation Trainer Regulatory Affairs

orangeglobal centre of competence

PSUR creation

071

Literature searches for PSURs

orangeglobal centre of competence

069

Creation of pharmacovigilance and risk management plans (EU-RMP)

Communication Science

Internationalisation: documents Trainer Pharmacovigilance Headline

orangeglobal centre of competence

067

III

International market research Trainer Headline Internationalisation and Master Creation

orangeglobal centre of competence

mARKET rESEARCH

Expert support pharmacovigilance

Regulatory Affairs

Page

Pharmocovigilance

orangeglobal SERVICES Internationalisation and Master Creation

Market Research

orangevillage expertS

Graphic Designer

Interviewer Legal practitioner Communication Scientist

Technology Expert

Terminologist

Technical Writer

Expert Software

Regulatory Writer

Regulatory Affairs Expert

Quality Manager

Process Analyst

Programmer

Pharmacovigilance Expert

Notary

National Country Expert

Native speaker + Medical Specialist

Medical Writer

Media Designer

Marketing Expert

Localisation Expert

Liaison Manager

Editor

International Market Researcher

Photographer

Expert

eSubmission Expert

Desktop Publisher

Printer

Interpreter and Speaker

Clinical Trial Expert

Creative Writer

Specialist Audio Typist

orangevillage expertS

orangeglobal | 46

Regulatory Affairs

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Communication Science

Regulatory Affairs

Page

Pharmocovigilance

orangeglobal SERVICES Internationalisation and Master Creation

Market Research

orangeglobal centre of competence

MedDRA control tool

Comparison with terminology databases

QRD quality control

Reference safety information (RSI): creation and harmonisation

International labelling creation: PIL

Labelling creation international: summary of product characteristics and labelling

Document and content management

eCTD formatting and compilation

NTA to eCTD updates

Medical writing

Regulatory writing

Abstract writing: summary of research results

International literature searches

Evaluation of registration dossiers

Clinical trial labelling translation

Printer

Desktop Publisher

eSubmission Expert

Graphic Designer International Market Researcher Interviewer Legal practitioner Communication Scientist

Terminologist

Technology Expert

Regulatory Writer

Regulatory Affairs Expert

Technical Writer

Expert Software

Quality Manager

Process Analyst

Programmer

Pharmacovigilance Expert

Notary

National Country Expert

Native speaker + Medical Specialist

Media Designer

Medical Writer

Marketing Expert

Localisation Expert

Liaison Manager

Editor

Photographer

Specialist Audio Typist

Expert

Interpreter and Speaker

Clinical Trial Expert

Creative Writer

orangevillage expertS fachexperten orangevillage

orangeglobal | 48

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Communication Science

Regulatory Affairs

Page

Pharmocovigilance

orangeglobal SERVICES Internationalisation and Master Creation

Market Research

orangeglobal centre of competence

Regulatory Affairs

Test for translation friendliness

Acceptance test for international company terminology

Company terminology and corporate wording: analysis and standardisation worldwide

Text optimisation by orangetextcontrol

Objective comprehensibility analysis: CBS

orangeglobal centre of competence

Strategic product communication: analysis of international sector and customer communication

Communication Science

Resolving deficiencies and fulfilling international conditions

Variation management

Expert support: international authority contacts

Product information management (PIM): migration to maintenance

Translation for the national phase in the CP, DCP and MRP

Readability compliance: bridging

Readability compliance: European readability test

Typesetting of international labelling documents

orangevillage expertS

Technical Writer Technology Expert Terminologist

Expert Software

Regulatory Writer

Regulatory Affairs Expert

Quality Manager

Process Analyst

Programmer

National Country Expert Pharmacovigilance Expert

Notary

Native speaker + Medical Specialist

Media Designer

Medical Writer

Marketing Expert

Communication Scientist

Localisation Expert

Liaison Manager

Legal practitioner Editor

Interviewer

International Market Researcher

Graphic Designer

Photographer

Expert

eSubmission Expert

Desktop Publisher

Printer

Interpreter and Speaker

Clinical Trial Expert

Creative Writer

Specialist Audio Typist

orangevillage expertS

orangeglobal | 50

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Communication Science

Regulatory Affairs

Page

Pharmocovigilance

orangeglobal SERVICES Internationalisation and Master Creation

Market Research

orangeglobal centre of competence

Communication Science

Translation memory: alignment

Translation with translation memory

orangeglobal centre of competence

Text optimisation by orangetextcontrol

Optimisation of regulatory, technical and medical source texts (creation of master documents)

Source text analysis

077

Language, Translation and Localisation

VII

Seminars: international text creation (comprehensibility, writing for the web, usability)

Creation of international audio documents

Comparison of medical documents with terminology databases

Creation of internationalised design templates

Pictograms: international visualisation of product use

Communication science-based optimisation of multilingual training documents

Creation of multilingual communication rules and instructions

International usability tests: home-use studies

International Analysis of user behaviour: eye tracking

orangevillage expertS

Process Analyst Quality Manager Regulatory Affairs Expert

Terminologist

Technology Expert

Technical Writer

Expert Software

Regulatory Writer

Programmer

Pharmacovigilance Expert

National Country Expert Notary

Native speaker + Medical Specialist

Media Designer

Communication Scientist

Medical Writer

Marketing Expert

Localisation Expert

Liaison Manager

Editor

Legal practitioner

Interviewer

International Market Researcher

Graphic Designer

Photographer

Expert

eSubmission Expert

Desktop Publisher

Printer

Interpreter and Speaker

Clinical Trial Expert

Creative Writer

Specialist Audio Typist

orangevillage expertS

orangeglobal | 52

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Communication Science

Regulatory Affairs

Pharmocovigilance

Seite

Language, Translation and Localisation

VII

Internationalisation and Master Creation

Page

orangeglobal SERVICES

Market Research

orangeglobal centre centre of of competence competence orangeglobal

Translation: pharmacovigilance translation 53

Translation: patent translation

Translation: high-speed translation

Translation: back-translation for quality control

Translation: attested faithful translation

Translation: faithful translation

Translation: free translation

Translation: DIN EN 15038-compliant translation

Translation: basic/1-to-1 translation

Creation of style guides: style guides governing linguistic and formal style

Creation of translation guides: translation guides based on customer briefing

Quality control tools

Sector-specific terminology databases

Terminology management: construction and maintenance of terminology databases

Terminology extraction

eSubmission Expert

Expert

Specialist Audio Typist

Photographer

Graphic Designer International Market Researcher Interviewer Legal practitioner

Marketing Expert Medical Writer

Pharmacovigilance Expert

Regulatory Affairs Expert

Technical Writer

Terminologist

Technology Expert

Expert Software

Regulatory Writer

Quality Manager

Process Analyst

Programmer

National Country Expert Notary

Native speaker + Medical Specialist

Media Designer

Localisation Expert

Liaison Manager

Editor

Communication Scientist

Desktop Publisher

Printer

Interpreter and Speaker

Creative Writer

Clinical Trial Expert

orangevillage expertS fachexperten orangevillage

orangeglobal | 54

VII

Language, Translation and Localisation

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Communication Science

Regulatory Affairs

Page

Pharmocovigilance

orangeglobal SERVICES Internationalisation and Master Creation

Market Research

orangeglobal centre of competence

Localisation: website localisation

Localisation: software localisation

Localisation: cultural and political localisation

Legal adaptation of translations

orangeglobal language server

Proofreading by foreign subsidiaries: co-ordination of and responsibility for document release international

Proofreading proofs

Proofreading and correcting

Quality editing

Attestations or certificates

MedDRA control tool

Translation: machine translation

Translation: clinical trial labelling translation

QRD quality control

Translation for the national phase in the CP, DCP and MRP

Interviewer Legal practitioner

Medical Writer

Programmer

Technology Expert Terminologist

Technical Writer

Expert Software

Regulatory Writer

Regulatory Affairs Expert

Quality Manager

Process Analyst

Pharmacovigilance Expert

Notary

National Country Expert

Native speaker + Medical Specialist

Media Designer

Localisation Expert Marketing Expert

Liaison Manager

Editor

Communication Scientist

International Market Researcher

Graphic Designer

Photographer

Expert

eSubmission Expert

Desktop Publisher

Printer

Interpreter and Speaker

Clinical Trial Expert

Creative Writer

Specialist Audio Typist

orangevillage expertS

orangeglobal | 56

VII

Language, Translation and Localisation

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Communication Science

Regulatory Affairs

Page

Pharmocovigilance

orangeglobal SERVICES Internationalisation and Master Creation

Market Research

orangeglobal centre of competence

Interpreting

Speech recordings, synchronisation and voice-over

Audio transcribing: transcription

Multilingual subtitling

Layout of localisable labelling templates

(Multilingual) desktop publishing (dtp)

Claim, slogan and citation: user and association test

Claim, slogan and citation translation and localisation

Claim, slogan and citation analysis

Language optimisation by medical writing

Language optimisation by technical writing

Language optimisation by regulatory writing

Language optimisation by creative writing

Checklist for localisation control

Medical Writer

Marketing Expert

Terminologist

Technology Expert

Technical Writer

Expert Software

Regulatory Writer

Regulatory Affairs Expert

Quality Manager

Process Analyst

Programmer

National Country Expert Pharmacovigilance Expert

Notary

Native speaker + Medical Specialist

Media Designer

Localisation Expert

Communication Scientist Liaison Manager

Legal practitioner

Interviewer

International Market Researcher

Graphic Designer

Photographer

Specialist Audio Typist

Expert

eSubmission Expert

Desktop Publisher

Printer

Interpreter and Speaker

Clinical Trial Expert

Creative Writer

Editor

orangevillage expertS

orangeglobal | 58

VIII Marketing Support

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Communication Science

Regulatory Affairs

Page

Pharmocovigilance

orangeglobal SERVICES Internationalisation and Master Creation

Market Research

orangeglobal centre of competence

Final artwork

Image processing and postproduction

Proofreading and correcting

Localisation and translation

Objective comprehensibility analysis: CBS

Expert support: international marketing

Photographic productions international

(Multilingual) desktop publishing (dtp)

Branding of international product information texts

Creation of multilingual multimedia presentations

Creation of international company logos

Visualisation of official documents

Visualisation of international marketing materials

Creation of internationalised graphics and icons

International webdesign for multilingual websites

Interpreter and Speaker

Printer

Desktop Publisher

Expert

Communication Scientist

Terminologist

Technology Expert

Technical Writer

Expert Software

Regulatory Affairs Expert

Regulatory Writer

Quality Manager

National Country Expert

Native speaker + Medical Specialist

Process Analyst

Programmer

Pharmacovigilance Expert

Media Designer

Medical Writer

Marketing Expert

Notary

Localisation Expert

Liaison Manager

Editor

Legal practitioner

International Market Researcher

Graphic Designer Interviewer

Photographer

Specialist Audio Typist

eSubmission Expert

Clinical Trial Expert

Creative Writer

orangevillage expertS fachexperten orangevillage

orangeglobal | 60

VIII Marketing Support

Technology and Engineering

Marketing Support

Language, Translation and Localisation

Communication Science

Regulatory Affairs

Page

Pharmocovigilance

orangeglobal SERVICES Internationalisation and Master Creation

Market Research

orangeglobal centre of competence

Information management: content and document management systems (CMS/DMS) 61

Information management: product information management (PIM)

Text analysis: Text optimisation by orangetextcontrol

Editorial systems: medical lay term dictionary

Editorial systems: co-authoring tools

Language processes: machine translation

Language processes: quality control tools

orangeglobal centre of competence

Language processes: MedDRA control tool

Language processes: website localisation

Language processes: software localisation

Language processes: terminology management - construction and maintenance of terminology databases

Language processes: translation memory

083

Technology and Engineering

Print: nearshore or offshore

Lithography/EIP (reproduction)

orangevillage expertS Interviewer Legal practitioner Communication Scientist Editor

Localisation Expert

Pharmacovigilance Expert Programmer

Terminologist

Technology Expert

Technical Writer

Regulatory Writer

Expert Software

Regulatory Affairs Expert

Quality Manager

Process Analyst

Notary

National Country Expert

Native speaker + Medical Specialist

Media Designer

Medical Writer

Marketing Expert

Liaison Manager

International Market Researcher

Graphic Designer

Photographer

Expert

eSubmission Expert

Desktop Publisher

Printer

Interpreter and Speaker

Clinical Trial Expert

Creative Writer

Specialist Audio Typist

orangevillage expertS

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Technology and Engineering

Marketing Support

Communication Science

Language, Translation and Localisation

Regulatory Affairs

Pharmocovigilance

Seite

Technology and Engineering

Internationalisation and Master Creation

Page

orangeglobal SERVICES

Market Research

orangeglobal centre centre of of competence competence orangeglobal

Provision of support tools

Training

Process integration: support tools for foreign language strategy

International technology tenders: organisation, implementation and evaluation

Expert support: technology and engineering

Information management: orangeglobal Language Server

Desktop Publisher

eSubmission Expert

Expert

International Market Researcher Interviewer Legal practitioner Communication Scientist Editor Liaison Manager Localisation Expert Marketing Expert Medical Writer Media Designer Native speaker + Medical Specialist

Terminologist

Technology Expert

Technical Writer

Expert Software

Regulatory Writer

Regulatory Affairs Expert

Quality Manager

Process Analyst

Programmer

Pharmacovigilance Expert

Notary

National Country Expert

Graphic Designer

Photographer

Specialist Audio Typist

Printer

Interpreter and Speaker

Clinical Trial Expert

Creative Writer

orangevillage expertS fachexperten orangevillage

orangeglobal | 64

orangeglobal Centre of Competence

text MARKET RESEARCH Knowledge gives the edge. The orangeglobal Centre of Competence Market Research provides support during the analysis and formulation of global market requirements. Valuable information for the planning of products to be marketed internationally is gained through the results of global market research. The services of the orangeglobal Centre of Competence Market Research primarily form the basis of further services from the orangeglobal Centres of Competence.

International market research

orangeglobal

III III

orangeglobal Centre of Competence

text Internationalisation and Master Creation The consistent consideration of internationalisation is a source of efficient, hyperlocal product placement on global markets. The internationalisation process results in a master, which is neutral in cultural and language terms. Efficient localisation for all target groups is only possible using this master, so that the costs of globalisation processes are transparent from the outset, quality is assured, short time-to-market is possible with no delays. The orangeglobal Centre of Competence Internationalisation and Master Creation takes on and focuses on neutralisation, ideally at the product planning / document production stage. Internationalisation forms the basis of all the globally-orientated services from the orangeglobal Centres of Competence.

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International master creation Internationalisation: documents

orangeglobal

orangeglobal Centre of Competence

text PHARMACOViGILANCE The orangeglobal Centre of Competence Pharmacovigilance provides active support during administrative and document-related tasks from the field of pharmacovigilance.

Supplementary services are also found in the orangeglobal Centres of Competence Regulatory Affairs and Language, Translation and Localisation.

Risk evaluation for market registration Expert support pharmacovigilance Creation of pharmacovigilance and risk management plans (EU-RMP) Risk surveillance Literature searches for PSURs PSUR creation Translation: pharmacovigilance translation

orangeglobal

orangeglobal Centre of Competence

text REGULATORY AFFAIRS The national market launch of a product demands adherence to all official rules, regulations and laws. The orangeglobal Centre of Competence Regulatory Affairs ensures the conformity of the international licensing documentation and problem-free communication with national authorities.

Supplementary services are also found in the orangeglobal Centres of Competence Communication Science and Language, Translation and Localisation.

International regulatory expert consulting Optimisation of international regulatory strategy Expert support: international regulatory affairs Scientific support: international regulatory affairs Seminars: international regulatory affairs Clinical trial support international Multinational clinical trial labelling creation Clinical trial labelling translation Expert report and dossier creation Evaluation of registration dossiers International literature searches Abstract writing: summary of research results Regulatory writing Medical writing NTA to eCTD updates eCTD formatting and compilation Document and content management Labelling international Labelling creation international: summary of product characteristics and labelling International labelling creation: PIL Reference safety information (RSI): creation and harmonisation QRD quality control

orangeglobal

orangeglobal Regulatory Affairs

REGULATORY AFFAIRS Comparison with terminology databases MedDRA control tool Typesetting of international labelling documents Readability compliance: European readability test Readability compliance: bridging Translation for the national phase in the CP, DCP and MRP Product information management (PIM): migration to maintenance Market registration in target markets, international authority contacts Expert support: international authority contacts International market registration maintenance Variation management Resolving deficiencies and fulfilling international conditions Examples of orangeglobal processes EXAMPLES OF orangeglobal processES Regulatory affairs management: readability compliance - cost and time reduction by bridging Regulatory affairs management: harmonisation and centralisation Regulatory affairs management: fulfilment of EMA PIM requirements

59 73

orangeglobal

orangeglobal Centre of Competence

text communication science The core competence of the orangeglobal Centre of Competence Communication Science lies primarily in the communication science-related and consequently objective preparation of the master. The main focus is on appeal to the target groups and on the legibility and comprehensibility of documents.

Supplementary services are also found in the orangeglobal Centres of Competence Regulatory Affairs and Language, Translation and Localisation.

Analysis of international corporate and product communication Strategic product communication: analysis of international sector and customer communication Objective comprehensibility analysis: CBS Text optimisation by orangetextcontrol Company terminology and corporate wording: analysis and standardisation worldwide Acceptance test for international company terminology Test for translation friendliness International Analysis of user behaviour: eye tracking International usability tests: home-use studies Optimisation of international corporate and product communication Creation of multilingual communication rules and instructions Communication science-based optimisation of multilingual training documents Pictograms: international visualisation of product use Creation of internationalised design templates Comparison of medical documents with terminology databases Creation of international audio documents Seminars: international text creation (comprehensibility, writing for the web, usability)

orangeglobal

VII

orangeglobal Centre of Competence

text LANGUAGE, TRANSLATION AND LOCALISATION Positioning products on global markets demands the internationalisation or creation of the master, plus the translation and localisation of information. Supporting tools and optimum translation preparation enable language processes to be structured more efficiently. As a globalisation partner, orangeglobal is in a position to optimise the frequently cumbersome and cost-intensive language and translation processes, thereby producing high quality and efficient results. The orangeglobal Centre of Competence Language, Translation and Localisation works exclusively with native speakers, who are experts in the specialist field of the document in question. The services of the orangeglobal Centres of Competence Language, Translation and Localisation can ideally be combined with the services offered by the other orangeglobal Centres of Competence.

Translation preparation services Source text analysis Optimisation of regulatory, technical and medical source texts (creation of master documents) Text optimisation by orangetextcontrol Translation with translation memory Translation memory: alignment Terminology extraction Terminology management: construction and maintenance of terminology databases Sector-specific terminology databases Quality control tools Creation of translation guides: translation guides based on customer briefing Creation of style guides: style guides governing linguistic and formal style Translation variants Translation: basic/1-to-1 translation Translation: DIN EN 15038-compliant translation Translation: free translation Translation: faithful translation Translation: attested faithful translation Translation: back-translation for quality control Translation: high-speed translation Translation: patent translation Translation: pharmacovigilance translation Translation for the national phase in the CP, DCP and MRP

VII

orangeglobal

VII

orangeglobal Centre of Competence

LANGUAGE, TRANSLATION AND LOCALISATION QRD quality control Translation: clinical trial labelling translation Translation: machine translation MedDRA control tool Proofreading and certificates Attestations or certificates Quality editing Proofreading and correcting Proofreading proofs Proofreading by foreign subsidiaries: co-ordination of and responsibility for document release international orangeglobal language server Localisation and language optimisation Legal adaptation of translations Localisation: cultural and political localisation Localisation: software localisation Localisation: website localisation Checklist for localisation control Language optimisation by creative writing Language optimisation by regulatory writing Language optimisation by technical writing Language optimisation by medical writing

Marketing localisation Claim, slogan and citation analysis Claim, slogan and citation translation and localisation Claim, slogan and citation: user and association test Layout international and (multilingual) desktop publishing (dtp) (Multilingual) desktop publishing (dtp) Layout of localisable labelling templates Language media and interpreting Multilingual subtitling Audio transcribing: transcription Speech recordings, synchronisation and voice-over Interpreting Examples of orangeglobal processes Translation management: cost reduction in in-house communication Translation management: translation programming

VII

orangeglobal

VIII

orangeglobal Centre of Competence

text MARKeting support The most extensive solution is not always the best. The orangeglobal Centre of Competence Marketing Support, working together with advertising agencies, supports the important, potentially low budget tasks associated with global campaigns, from visualisation for specific target groups right up to the pre-press stage.

VIII

Supplementary services are also found in the orangeglobal Centres of Competence Language, Translation and Localisation and also Technology and Engineering.

Visualisation of international marketing materials: creative design, implementation and optimisation International webdesign for multilingual websites Creation of internationalised graphics and icons Visualisation of international marketing materials Visualisation of official documents Creation of international company logos Creation of multilingual multimedia presentations Branding of international product information texts (Multilingual) desktop publishing (dtp) Photographic productions international Group targeting through international marketing materials Expert support: international marketing Objective comprehensibility analysis: CBS Localisation and translation Proofreading and correcting Pre-press Image processing and postproduction Final artwork Lithography/EIP (reproduction) Print: nearshore or offshore

VIII

orangeglobal

orangeglobal Centre of Competence

text TECHNOLOGY AND ENGINEERING The orangeglobal Centre of Competence Technology and Engineering develops, seeks out, analyses and implements new or established technologies, which systematically support document preparation. It ensures efficient incorporation into existing client systems. Certain tools can also be supplied by the orangeglobal Centre of Competence Technology and Engineering. Supplementary services are also found in the orangeglobal Centres of Competence Language, Translation and Localisation.

Software: solutions Language processes: translation memory Language processes: terminology management - construction and maintenance of terminology databases Language processes: software localisation Language processes: website localisation Language processes: MedDRA control tool Language processes: quality control tools Language processes: machine translation Editorial systems: co-authoring tools Editorial systems: medical lay term dictionary Text analysis: Text optimisation by orangetextcontrol Information management: product information management (PIM) Information management: content and document management systems (CMS/DMS) Information management: orangeglobal language server Technological support and consulting Expert support: technology and engineering International technology tenders: organisation, implementation and evaluation Process integration: support tools for foreign language strategy Training Provision of support tools

orangeglobal

orangeglobal Business Services GmbH Am Sudhaus 9, 89077 Ulm Managing director: Harald Schmid Tel +49 (0) 731 / 954 95 50 Amtsgericht Ulm HRB 1672 Fax +49 (0) 731 / 954 95 30 VAT-ID-No. DE 147035118 Fax +49 (0) 731 / 954 95 60 Tax-No. 88003/58758 E-Mail: mail@orangeglobal.de Internet: www.orangeglobal.de orangeglobal Customer Relations in (scientific) Business Development and Scientific Affairs Contact orangeglobal Business Development if you have general questions about orangeglobal services, need a quote or want help with a particular question. orangeglobal Service - we would be happy to organise for you: - Online presentations on subjects of relevance to you - Specialist discussions and workshops with orangeglobal experts â&#x20AC;&#x201C; by telephone or on site with you Dr. Gunnar Box Director Scientific Affairs gunnar.box@orangeglobal.de +49 (0) 731 / 954 95 18

Dr. Njikoha Ebigbo Customer Relation Management Management Board njikoha.ebigbo@orangeglobal.de +49 (0) 731 / 95495-15

orangeglobal