The Scientific business of Thomson Reuters works with an international network of consultants, each with in-depth local expertise. As a result, each module in the IDRAC database contains Regulatory Summaries focused specifically on the module’s region, written by experts from the region.

Our approved consultants can provide individual services, supplementary to an IDRAC subscription.

We are proud of our worldwide consultant network which includes the following, by country.

IDRAC DATABASE: CONSULTANTS - ARGENTINA, CHILE, COLOMBIA

Sociedad De Validacion de Sistemas - SVS
Av. Del Libertador 6550, 2B, C1428ARV - Ciudad de Buenos Aires ARGENTINA

T: +54 11 4343-3000
F: +54 11 4343-7744
W: svshome.com

Mr. Agustín M. Iglesias Diez
E: agustin.iglesias@svshome.com

SVS is the leading validation and compliance consulting company in Spain, Argentina, Italy, China and Algeria.

Our mission is to provide high-value validation and compliance services to our customers.

Our goal is to offer to our customers a complete and integrated range of validation and compliance services through a flexible, practical, objective, cost-minimizing and investment-optimising approach.

SERVICES PROVIDED IN THE FOLLOWING AREAS:

- Regulatory Affairs Consulting Services (Implementation of national and international regulations related to registration, review of dossiers and assessment of their level of compliance with current regulations).

- Strategic partners: (MA, marketing licenses, market studies, assistance to foreign companies to enter the local market).

- Compliance Auditing Services: (Integral diagnosis and pre-inspection / pre-approval audit, Audit of compliance with the CFR 21 part 11 regulation regarding computerized systems, Audit of suppliers, Quality Assurance Systems audit and ISO 9000 audit).

- Quality System Consulting Services (Consultancy and Inspection Preparations, Quality Assurance)

- Validation Services: (based on a quality system and the use of our own high quality.

- IT System Lifecycle Management: introducing Good Practices for information Systems.

- Training solutions (in-company training).

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IDRAC DATABASE: CONSULTANTS - ASEAN, HONG KONG, MALAYSIA, SINGAPORE, TAIWAN

Omnicare Clinical Research

T: +49 6196 5228 350
F: +49 6196 5228 155
W: omnicarecr.com

Martine Delingher-Kremer
E: martine.dehlinger-kremer@omnicarecr.com

RIGHT FROM THE START, RIGHT TO THE END

Are you looking for reliable regulatory consulting that works diligently for you? At Omnicare Clinical Research, our Regulatory Affairs professionals are dedicated to ensuring the successful and timely submission of your application. We work closely with you, from project initiation to completion, to determine your specific business needs and to meet your timelines. Our experts can provide the strategic regulatory guidance to:

- Expedite the compilation and submission of your application

- Produce a submission acceptable to local and/or global regulatory authorities

- Facilitate regulatory review to achieve faster study initiation or product approval

THE ROAD TO SUCCESS

Success speaks for itself. Omnicare Clinical Research has contributed to the successful approval of numerous regional and global investigational and marketing applications without receiving any notifications of clinical hold/objection or refusals to file. To date, these submissions include 58 NDAs/BLAs, 24 MAAs (including CTDs), 124 national filings (including CTDs), 7 Orphan Drug applications and many INDs, CTAs, and CTNs. Our 100% global success rate demonstrates that we have the ability to manage submissions worldwide, the experience to meet timelines and the drive to produce results.

COMMITMENT TO QUALITY

Selecting the right consultant is critical to ensuring the quality and success of your project. At Omnicare Clinical Research, we understand that a properly-prepared submission is critical to the approval process of your application. We meticulously review all submissions for completeness and assemble each submission according to regulatory requirements. Our regulatory track record demonstrates our commitment to quality. When you trust your project to our regulatory experts, you gain the extensive experience and unparalleled success that is the hallmark of Omnicare Clinical Research.

READY TO DELIVER

Experience ensures readiness for any challenge. Omnicare Clinical Research has the global regulatory expertise and the knowledge of applicable regulations to oversee submissions to U.S., EU, Japan, Asia-Pacific and Canadian regulatory authorities. Examples of our services include:

- Regional and global product development and registration strategy

- Compliance audits for good clinical/laboratory/manufacturing practices (GXPs)

- Drug import/export

- Implementation of internal change control systems

- Report preparation/publishing/submission

- Clinical trial authorizations (e.g., IND, CTA)

- Marketing authorization dossiers (e.g., NDA, MAA, dossiers in CTD format)

- Creating prescribing information

- Assessing advertising and promotional materials

- Regulatory authority liaison

- Regulatory intelligence/due diligence

- Post submission support (e.g., annual reports, amendments, variations)

- Training seminars

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IDRAC DATABASE: CONSULTANTS - AUSTRALIA

SYMBIOTIC RESEARCH Pty. Ltd.
c/o Aoris Nova Pty Ltd
1 Central Avenue
The Australian Technology Park
Eveleigh NSW 1430
AUSTRALIA

T: +61 2 9209 4234
F: +61 2 9209 4242

Dr Kelvin Hopper, Aoris Nova Pty Ltd
1 Central Ave
The Australian Technology Park
Eveleigh NSW 1430

T: +61 2 9209 4234
F: +61 2 9209 4242

E: khopper@aoris.com.au
W: aoris.com.au

Dr Isabelle Meyer-Carrive, ICP Firefly
1 Central Ave
The Australian Technology Park
Eveleigh NSW 1430

T: +61 2 9209-4258

E: isabellemc@icpfirefly.com.au
W: icpfirefly.com.au

Dr David Sarson, Director Delpharm Consultants Pty Ltd
Suites 211 & 212
5 Alexander Street

T: +612 9966 8622
F: +61 2 9966 9244

E: delphar@bigpond.net.au

CROWS NEST NSW 2065

W:delpharm.com.au

Symbiotic research is a joint venture company of three partners providing contract research and business development of biotechnology, pharmaceutical, devices and diagnostic product. This is a unique and comprehensive combination set of skills to bring a product through preclinical and clinical trials to market in a pragmatic and business environment with understanding of the international regulatory scene.

The company was formed in 1997 from three companies with longstanding (over 8 years each) and extensive, recognised, experience in the health, life science and biotech industries in Australia and the region.

A FULL RANGE OF SUPPORT INCLUDES:

- Project Management

- Regulatory affairs including EU, FDA, CSA, TGA

- Manufacturing feasibility and sourcing, conformation to GMP and GLP.

- Preclinical studies including product efficacy trials and toxicology using animal and in vitro methods conforming to ISO 9001, and GLP

- Clinical trial management to GCP standards

- Business Development and commercialisation

- Fundraising and strategic partnerships

We provide thorough understanding of the Australian regulatory scene in the international market for efficient and cost effective product development; commitment of a project manager who will ensure continuity of each step of the assignment; and potential cost benefits due to:

- Marketing authorization: Marketing authorization of medicinal products in the EU

- eCTD: Preparation/reformatting of the registration dossier

- Pricing strategies: Evaluation of pricing strategies for the Austrian market

- Reimbursement applications: Inclusion in the Code of Reimbursement

- Pharmacovigilance: Taking over of pharmacovigilance activities

- MedDRA: MedDRA coding for pharmacovigilance and PSURs

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IDRAC DATABASE: CONSULTANTS - AUSTRIA

ARAC (At Regulatory Affairs Consulting GMBH)
Kirchengasse. 48/3,
1070 Vienna,
AUSTRIA

T: +43 1 524 05 89 - 10
F: +43 1 524 05 89-90

Dr. Ingrid Huber-Strubl
E: huber@aracgmbh.com

ARAC (At Regulatory Affairs Consulting GMBH) is a team of experts specializing in the marketing authorization of medicinal products, eCTD, pricing and reimbursement strategies, and pharmacovigilance. The company is based in Vienna, near the centre of the city.

THE COMPANY OFFERS THE FOLLOWING SERVICES:

- Marketing authorization: Marketing authorization of medicinal products in the EU

- eCTD: Preparation/reformatting of the registration dossier

- Pricing strategies: Evaluation of pricing strategies for the Austrian market

- Reimbursement applications: Inclusion in the Code of Reimbursement

- Pharmacovigilance: Taking over of pharmacovigilance activities

- MedDRA: MedDRA coding for pharmacovigilance and PSURs

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IDRAC DATABASE: CONSULTANTS - BALTIC COUNTRIES (ESTONIA - LATVIA - LITHUANIA)

DOKUMEDS
Brivibas 195 office 66
Riga
LV-1039
LATVIA

T: +371 67 553 065
F: +371 67 545 295

Dr Indra Aboltina, Managing Director
E: indra.aboltina@dokumeds.lv
E: dokumeds@dokumeds.lv
W: www.dokumeds.lv

DOKUMEDS supports phase II, III and IV clinical trials.

SERVICES INCLUDE:

- Project Management

- Extensive clinical investigator network

- Selection and set up of study sites

- Effective study monitoring

- Excellent GCP education

- High quality regulatory affairs management

- Development planning

- Trial design

- Bioavailability studies

- Data management and statistical analysis

- Medical writing

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IDRAC DATABASE: CONSULTANTS - BELGIUM

SGS Belgium
Chemin du Poète, 10
B 1301 Wavre
BELGIUM

T: +32 10 42 11 11
F: +32 10 42 11 00 / +32 10 42 11 30

Valérie Hennuy
E: valerie.hennuy@sgs.com

SGS Life Science Services, a Business unit of the SGS Group, has 30 years of experience as a global contract service organization providing integrated solutions from preclinical activities to Phase I through IV trials, bio-analytical and QC testing. With more than 1,300 employees and 2,000 clinical trials performed, SGS Life Science Services serves the pharmaceutical, biotechnology and medical device industries.

SGS enables clients to improve efficiency in drug development timelines and decision making.

The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. With more than 50,000 employees, SGS operates a network of more than 1,000 offices and laboratories around the world.

Additional information about SGS is available at www.sgs.com/CRO.

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IDRAC DATABASE: CONSULTANTS - BRAZIL

SILVIA V. FRIDMAN e ASSOCIADOS
Rua Canário 956/112
São Paulo - SP
04521-004
BRAZIL

T: +55 (11) 5543 6586
M: +55 (11) 9157 3730
F: +55 (11) 5543 658

Silvia Vaisbich Fridman
E: silvia@fridman.com.br

Silvia V. Fridman e Associados was established in 1998 with the main objective of working as a close partner with companies that carry out activities related to products subject to the Sanitary Surveillance System including: Medicinal products; Cosmetic products; Health products and Sanitary products.

Current and past clients include the former Brazilian Pharmaceutical Industry Association (ABIFARMA) currently, the Brazilian Pharmaceutical Industry Federation (FEBRAFARMA), The Brazilian Active Pharmaceutical Ingredient Association (ABIQUIF), The International Drug Registration Assisted by Computer- IDRAC (an international regulatory intelligence database); multinational and national pharmo-chemical (APIs) and pharmaceutical laboratories in Brazil, wholesalers and distributors of medicinal products.

Silvia V.Fridman e Associados provides operational, strategic and organizational consulting and supportive services in regulatory affairs and sanitary surveillance and in pharmaceutical marketing support.

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IDRAC DATABASE: CONSULTANT - BULGARIA

Assoc. Prof. Tatyana Benisheva-Dimitrova PhD, MD
1111, Sofia
49 A Hristo Maximov Str
BULGARIA

T: +359 8 737 667
F: +359 2 731 202

Dr. Tatyana Benisheva-Dimitrova
E: benicheva_tb@yahoo.com

Dr. Tatyana Benisheva-Dimitrova is Associated Professor on Drug Regulatory Affairs at the Faculty of Public Health at the Medical Academy in Sofia.

A former director of the drug policy department at the Ministry of Health in Bulgaria, she was directly responsible for establishing Bulgarian pharmaceutical legislation in 1995. She continues to shape this legislation thanks to her long tenure as a scientific expert at the Bulgarian Drug Agency and her thorough knowledge of medicinal procedures.

She was granted an EU-CADREAC scholarship and completed an MD in Drug Regulatory Affairs (2004/2005) at Bonn University.

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IDRAC DATABASE: CONSULTANTS - CANADA

CANREG INC.
4 Innovation Drive
Dundas, Ontario
L9H 7P3
CANADA

T: (905) 689 3980
F: (905) 689 1465
W: canreg.ca

Ms. Anne Tomalin
E: atomalin@canreg.ca

CanReg Inc. is one of Canada’s premium consulting companies offering market access for healthcare technology.

The company provides assistance in drug and device registrations in Canada, including: New Drug Submissions, Investigational New Drug Submissions, DIN Applications and Device Registration.

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IDRAC DATABASE: CONSULTANTS - CHINA

Excel PharmaStudies Inc.
8/F, Zhong Tian Building
A5# De Wai Avenue
Xi Cheng District
Beijing 100088
CHINA

T: +86-10-8208 1414 / ++86-10-8208 2424
F: +86-10-8208 1394
W: excel-china.com

Mark Engel, President
E: mark.engel@excel-china.com

Dr. Xu Ning, EVP, Business Development
E: ning.xu@excel-china.comp

Yao Zhong, Regulatory Affairs Manager
E: zhong.yao@excel-china.com

Excel is recognized by the pharmaceutical and healthcare industry as the leading Contract Research Organization (CRO) in China. Our staff has extensive experience and a track record of achievements in the various aspects of the industry.

OUR SERVICE COVERS:

- Product registration: Drug, Medical Device, Health Care Food, Cosmetics

- Consulting: From drug R & D to post-marketing

- Clinical trial: Phase I-IV, Import Registration Trial

- Out-licensing: Drug, Health Food

- Data management

- Biometrics

We are one of the few companies with experience in healthcare product and IND/NDA registration and management of GCP trials in China. We have already worked extensively with the Principal Investigators from many top clinical trial centers. In the past five years we have completed over 50 drug registrations and 60 clinical research projects in different therapeutic categories.

Based on the quality of services provided to our clients to date, we have established a reputation of excellence among many international companies. We maintain extensive contact networks and business relationships with key officials and personnel in the government departments (Ministry of Health, State Food and Drug Administration), industry, hospitals and institutional organizations.

In sum, now we become a leading CRO in China and are committed to providing excellent services to meet the needs of our clients and we have the experience and resources to do so.

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IDRAC DATABASE: CONSULTANTS - CZECH REPUBLIC

MiRo
Na Vapence 421
252 44 PSARY
CZECH REPUBLIC

Mgr. Romana Rožková

E: romana.rozkova@miro.cz

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IDRAC DATABASE: CONSULTANTS - DENMARK, FINLAND, NORWAY, SWEDEN

Weteko Publisher AB, c/o Wennerbeck
Dalbyvägen 29,
224 60 Lund
SWEDEN

Dr. Ingegerd Wennerbeck, MSc, Ph.D., assistant professor
T: +46(0)708182388
E: info@weteko.se

Dr Wennerbeck has been the owner and managing director of Novecon Research AB working as a consultant to the pharmaceutical industry for over 20 years. Before that she worked as Director of Research administration and Regulatory Affairs at Astra Draco in Lund. She has experience in project planning and in working with domestic as well as international marketing authorization dossiers and liaisons with regulatory authorities world-wide. As a consultant in Regulatory Affairs and Clinical Research she has been involved in giving advice on regulatory strategy, documentation requirement and overall plans for studies in humans. Dr Wennerbeck has also worked with submitting dossiers for marketing approval and clinical trial clearance in the Scandinavian countries as well as designing study protocols, case record forms, performing and supervising monitoring work for different type of clinical studies. She has been engaged in in-house training and lecturing on clinical as well as regulatory strategy.

Dr Wennerbeck has published approximately 15 papers in the area of organic chemistry and 12 papers in regulatory affairs area. Dr Wennerbeck is now working from her own company Weteko Publisher AB as a consultant to the pharmaceutical industry.

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IDRAC DATABASE: CONSULTANTS - EU,UNITED KINGDOM

Skeffington Consultants Ltd
Mrs Veronica Skeffington

E: all.skeffingtons@virgin.net

Veronica Skeffington has many years experience of working within the pharmaceutical industry and as a consultant. She has a particular expertise in regulatory legal and guideline requirements for the UK and EU. She is very active in professional Regulatory Affairs organisations, including acting as an examiner for courses for regulatory professionals.

FOR MEDICAL DEVICES COVERAGE:

Deavin Associates
Mr John Deavin
35 Kimbers, Petersfield, Hampshire
GU32 2JL
UK

T: +441730 262880
F: +441730 262880
E: deavinassociates.co.uk

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IDRAC DATABASE: CONSULTANTS - FRANCE

A.R.C. Pharma
152 Boulevard Malesherbes
75017 Paris
FRANCE

T: +33 1 47 64 63 50
T: +33 1 47 63 81 90
E: arc@arcphar.com

Ms. Sylvie Duliere
E: s.duliere@arcphar.com

Ms. Florence Busquet
E: f.busquet@arcphar.com

Founded in 1981, A.R.C. Pharma is a privately owned Regulatory Affairs Consultancy company (Biofides group) with well established reputation and experience in the pharmaceutical industry. Its team of 14 consultants has an extensive know-how in delivering tailored regulatory services to meet customer’s needs as well as in preparing and submitting regulatory technical dossiers and economic dossiers.

A.R.C. Pharma provides a very extended range of high quality regulatory advice and support services including:

- strategic regulatory advice and consulting support

- product registration and advertising strategy

- due diligence of pharmaceutical dossiers and facilities

- writing and compilation of EU CTD dossiers, variations and renewals

- national and European submissions and maintenance of dossiers

- interaction and meeting with agencies and experts

- transparency and pricing dossiers

- readability user testing

- regulatory training and seminars

- regulatory intelligence services and information circulars

- licensing and acquisitions

A.R.C. Pharma acts on behalf of over 200 companies mainly in Europe. The clients of A.R.C. Pharma range from small start-up biotech companies to large multinational pharmaceutical companies.

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IDRAC DATABASE: CONSULTANTS - GERMANY

EUDRAC GmbH
Waldhofer Strasse 102
D-69123 Heidelberg
GERMANY

T: +49 6221-825780
F: +49-6221-75522-0

W: www.eudrac.de
E: info@eudrac.com

Ute Junghanns, MSc Reg Affairs (TOPRA)
E: ute.junghanns@eudrac.de

EUDRAC GmbH is an independent European Drug Regulatory Affairs Consultancy established in 2002 and provides a wide range of services for regulatory affairs and clinical research to the pharmaceutical and medical device industry for the European market.

Regulatory affairs services on European and national regulatory and data requirements, the preparation/organisation of marketing authorisation dossiers in CTD format, conversion of other dossier formats into CTD as required for the European markets, centralised/mutual recognition and national marketing authorisation applications, support for responses to deficiency letters, maintenance of existing marketing authorisations (variation and renewal applications); writing services for documents needed for regulatory submissions (summary of product characteristics, patient information leaflets, labelling, CTD summaries) and translation services.

Clinical Research services include consulting services on European and national regulatory requirements, writing of the required Patient Informed Consent Forms in the respective national language, assistance for CRF and other document translations, insurance, labelling, ethics committee applications, clinical trial applications (IMPDs) for all EU Member States.

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IDRAC DATABASE: CONSULTANTS - GREECE

ZEINCRO HELLAS SA
30 Anapafseos str.,
152 35 Vrilissia, Athens
GREECE

T: +30 210 8047709
F: +30 10 6134695
W: zeincro.com

Mr. Andreas Moschos
E: amoschos@zeincro.com

Ms Christina Bratakou
E: cbratako@zeincro.com

Zeincro Hellas S.A. is a leading Greek – based company which operates as a contract organization to the pharmaceutical industry.

ZEINCRO HELLAS PROVIDES:

- Consultancy services and co-ordination of pre-clinical research projects

- Design, co-ordination, management, conduct and follow-up of phase I-IV clinical trials

- Data management, biostatistics, expert report, medical writing and pharmacoeconomic services

- Internet-based clinical trials using Hypernet with high level of encryption

- Regulatory affairs services including pharmacovigilance and national/international submissions

- Training services and organization of tailor made courses, meetings and seminars

- Business development, licensing-in and licensing-out products and marketing services

Zeincro Hellas clients’ are local and multinational pharmaceutical companies, medical centers, health funds, doctor’s associations, collaborating CROs etc.

For further details, please visit our site: www.zeincro.com

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IDRAC DATABASE: CONSULTANTS - HUNGARY

Martonyi és Kajtár Baker & McKenzie Attorneys at Law
Ügyvédi Iroda
Andrássy út 102
1062 Budapest
HUNGARY

T: +36 1 302 3330
F: +36 1 302 3331

Mr. Zoltán Barakonyi
E: zoltan.barakonyi@bakernet.com

Mrs. Tímea Pálos
E: timea.palos@bakernet.com

Ms. Helga Bíró
E: helga.biro@bakernet.com

Baker & McKenzie the world’s first global law firm, has over 60 offices in more than 30 countries. With the opening of the Budapest Office in 1987, Baker & McKenzie became the first Western law firm to establish an office in Central and Eastern Europe. Over the past 19 years, the Budapest Office became one of the largest law firms in Hungary and has developed extensive experience and expertise in several practice areas, including corporate and commercial law, competition law, public procurement law, mergers and acquisitions, project finance and banking, employment law, IT and telecommunications law, intellectual property law, tax law and real estate matters.

Being a member of the Firm’s European Pharmaceuticals and Health Care Practice Group, the Budapest Office advises pharmaceutical and health care clients, including a number of multinational pharmaceuticals companies, on a wide range of legal issues in connection with their operations. We advise our clients in connection with the regulatory and licensing aspects of research, manufacturing, distribution and marketing of medicinal products as well as borderline products (e.g. medical devices, cosmetics and foods). We have developed special expertise on clinical trials, pharmaceutical advertising and promotion. We assist our clients in price negotiations with the Government. We also advise our pharmaceutical and health care clients on various intellectual property and tax law related issues. The Pharmaceuticals and Health Care Practice Group of the Budapest Office consists of five lawyers who are actively involved in the above matters.

GLENEAGLES CRC PTE LTD PROVIDES:

- Feasibility Studies

- IRB/EC Submissions

- Clinical Coordinators

- Clinical Monitors

- Clinical Project Management

- Clinical Data Management

- Biostatistics

- Product Registration in Asia

- Regulatory Affairs

- Phase I Studies (BE, BA, PK, PD)

Our regional research network in Asia enables us to assist our clients in both a time- and cost-efficient manner in preparing regulatory submissions to the recruitment of patients. GCRC is able to ensure that all regulatory submissions adhere to the requirements of local regulatory authorities, thus expediting the clinical trial approval process and importation of investigational product for the conduct of the clinical trial.

GCRC has the experience and knowledge in conducting clinical trials across the Asia-Pacific region. We have an added advantage of operating within the local defines of the various Asian countries by having the knowledge of the local healthcare dynamics, cultures and languages to streamline clinical research.

Gleneagles CRC PTE Ltd is the only CRO to have won the Asian CRO of the Year Award (Singapore).

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IDRAC DATABASE: CONSULTANTS - INDIA, SOUTH KOREA, THAILAND, VIETNAM

GLENEAGLES CRC PTE. LTD
111 Somerset Road #11-02
Singapore Power Building
SINGAPORE 238164

T: +65 67373642
F: +65 64713642
W: gleneaglescrc.com

Dr Anjali
E: dranjali@gleneaglescrc.com

Gleneagles CRC PTE Ltd (GCRC) is an Asian clinical research service provider with offices in Singapore, Bangkok, Manila, Beijing, Shanghai and Jakarta. By 4th quarter 2006 GCRC will also have offices in Perth, Australia and Seoul, Korea. It is a wholly owned subsidiary of Gleneagles Hospital (a Parkway Holdings Group of Companies, www.pgh.com.sg).

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IDRAC DATABASE: CONSULTANTS - IRELAND

Akos, Ltd.
Akos Limited
The Coach House
Pipers Lane
Harpenden,
Herts AL5 1 AH
UK

T: +44 (0) 1582 766 339
F: +44 (0) 1582 764 327

E: group@akos.co.uk
W:akos.co.uk

Kevin Sherwood-Williams
E: ksw@akos.co.uk

AKOS Ltd is a well-established private company set up by the owner and CEO Paul Evans in 1986. One of its major focuses is on international Regulatory Affairs, where it offers a full range of services including strategic consultancy and planning, clinical trial authorisation applications, and preparation and management of single- and multi-country submissions for marketing approval. AKOS will undertake complete projects, or perform discrete tasks, according to client needs. Allied to Regulatory Affairs is Regulatory Compliance, offering a range of audit services of facilities, systems, data and reports to GCP and GMP standard. AKOS offers consultancy in drug development and support in planning and executing projects in the earlier stages of development, from pre-clinical through to proof-of-principle. This includes assistance with all aspects of early clinical research from protocol design through to data entry, statistical analysis and report writing. Akos provides drug safety monitoring and reporting services, as well as post-marketing pharmacovigilance.

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IDRAC DATABASE: CONSULTANTS - ISRAEL

Yaakov Cass, MSc. BSc.
FRPHARMS. LICENSED PHARMACIST ISRAEL

T: +972 506242663
T: +972 542187709
F: +972 8 214926

E: yaakov9999@walla.co.il
E:yaakov.cass@lbm.health.co.il

Mr. Yaakov Cass has been active in every aspect of pharmacy in Israel for over 30 years. In 1994 he was appointed by the Ministry of Heath to the position of regional pharmaceutical officer and sometime adviser to the Minister of Health. He is familiar with almost every aspect of pharmaceutical legislation in Israel and continues to shape future legislation, actively consulting with the uppermost echelons of the Ministry on a regular basis. He is frequently requested by Israeli pharmacists to assist in resolving pharmaceutical issues without the framework of his official position.

Outside the Ministry, Mr. Cass is a prolific lecturer and writer reflected by over 100 publications and presentations. He is an honorary lecturer to the Hebrew University School of pharmacy lecturing on the law of pharmacy in Israel.

He holds a master’s degree in clinical pharmacy from the University of Manchester and a fellowship of the Royal Pharmacy Society of Great Britain for distinction in the profession of pharmacy. In 2009 he received an ASHP scholarship to participate in the Boston Universities School of Management Pharmacy Leadership Program.

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IDRAC DATABASE: CONSULTANTS - ITALY

ReS servizi Srl
Via Cesare Beccarla, 88
I-00196 Roma
ITALY

T: +39 06 36004550
M: +39 339 3639907
F: +39 06 36091534

W:res-servizi.eu / res-servizi.it

Dr Liliana Civalleri
E:civalleri@res-servizi.it

ReS servizi is a client-oriented company providing consultancy services for medicinal products, biotechnology products, nutraceuticals, food supplements and medical devices.

The main areas covered include regulatory evaluations and strategies for generic products and new chemical entities; clinical trials; regulatory affairs; medical writing and pharmaco-economics studies.

Regulatory Affairs’ main consultancy services provided by ReS servizi include:

- Clinical trials in cardiovascular diseases, gynaecology, dermatology and rheumatology

- Pharmacovigilance Service for the National Pharmacovigilance system

- Marketing Authorization Application (MAA) including management, submission and post-submission support for National, Decentralized and Mutual Recognition Procedures

- eCTD: compilation / reformatting of dossiers

- Price / reimbursement applications including preparation / submission of price dossiers and price negotiation with the Italian Medicines Agency (AIFA)

- Post-marketing support: Type I / Type II Variations; Renewals

- Regulatory writing / revision of Patient Information Leaflet; Summary of Product Characteristics and Labelling; translations from English, French, German, Spanish

- Manufacturing Plant Authorisation Applications

- Management of the procedure for filing medical devices in the data bank (Repertorio Dispositivi Medici) of the Italian Ministry of Health

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IDRAC DATABASE: CONSULTANTS - JAPAN

Please speak to your IDRAC Account Manager for details of local consultants in Japan.

IDRAC DATABASE: CONSULTANTS – MÉXICO

Christel G. Brüggemann S.
Sombrerete No. 499-3
Col. Hipódromo- Condesa
MÉXICO

T: (52) 55 55-16-79-40
E: c_bruggeman@yahoo.com.mx

INDEPENDENT CONSULTANT

Offers consulting services in Mexican regulatory environment.

PRODUCTS AND SERVICES

Regulatory Affairs: Regulatory consulting and advice for Mexican Ministry of Health dossier submission, assessing documents.

Review of foreign “Dossier’s” and adapting them for Registration in Mexico.

DIFFERENT TOPICS

- Elaboration of Quality Manuals

- Good documentation practices and documentation system

- Instructor in GMP’s and related topics

- Training of personal in GMP’s, GCP’s, Monitoring

- Training of plant personal

- Technical Consultant in GMP’s

- Qualification of Designs for Pharmaceutical Plants

- Validation

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IDRAC DATABASE: CONSULTANTS - NETHERLANDS

Marijke Van Butsele
Manager PhRAse bvba
A. Rodenbachstraat 62
3010 Leuven
BELGIUM

T: +32 (0) 16 69 97 41
M: +32 (0) 498 54 11 14
F: +32 (0) 16 69 97 41

E: phrase@skynet.be
W: phrase-consulting.be/

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IDRAC DATABASE: CONSULTANTS - POLAND

BAKER & McKENZIE
Gruszczynski & Partners
Attorneys at Law LP
Focus Building
Al. Armii Ludowej 26
00-609 Warsaw
POLAND

T: +48 22 57 63 100
F: +48 22 57 63 200

W:bakernet.com
E: warsaw@bakernet.com

Paulina Kieszkowska
E: paulina.kieszkowska@bakernet.com

Baker & McKenzie is an international law firm established in 1949. Today, it conducts business in the world’s most significant financial and commercial centres, giving us unparalleled geographical coverage and has global network of 66 offices in 36 countries. The Warsaw Office was opened in 1992 and is now the largest office of Baker & McKenzie in Central and Eastern Europe.

The Warsaw Pharmaceutical Practice Group consists of lawyers with relevant legal, regulatory and industry experience, dedicated to providing advice on a wide range of legal issues to pharmaceutical companies of all sizes and who have well established contact lines with national approval authorities.

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IDRAC DATABASE: CONSULTANTS - PORTUGAL

PHARMaffairs, Pharmaceutical Consulting - Consultadoria, Lda.
Rua Torcato José Clavine n.° 9, 1° Dto
2800-710 ALMADA
PORTUGAL

T:+351 91 9303525
F: +351 21 2949619

W:pharmaffairs-consultants.com

Ana Gaspar
E:info@pharmaffairs-consultants.com

Pharmaffairs is a Regulatory Consulting Company with services focused on the Pharmaceutical Industry. Our team is specialized in Scientific and Regulatory Affairs and has a broad experience in the Medicinal and Healthcare Product sector.

Pharmaffairs provides Scientific and Regulatory Consultancy Services that match the specific needs of each Client.

Our areas of expertise include Human medicines, Veterinary medicines, Cosmetics, Medical Devices, Nutritional products and others.

Our main regulatory services include dossier preparations (all modules in CTD format) and submission through national, mutual recognition and decentralized procedures, Marketing Authorization maintenance activities (e.g.: Type I and II variations, labeling preparation and analysis, renewals, expert reports), Pharmacovigilance activities, Pricing and Reimbursement and submission of Clinical Trials Applications to the Competent Authority and Ethics Committee. Pharmaffairs also provides high quality technical translations and regulatory training.

Our Project Team offers high quality regulatory solutions, confidentiality and flexibility, with a rigorous fulfillment of timelines.

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IDRAC DATABASE: CONSULTANTS - ROMANIA

Lucian Bondoc
Partner
Salans
General C. Budisteanu 28-C
010775 Bucharest, Romania

T:+40 21 312-4950
F:+40 21 312-4951

W:salans.com
E:lbondoc@salans.com

Salans is an international law firm conducting business with 20 offices in 16 countries, including the world’s most significant financial and commercial centers. Salans’ Bucharest Office is one of the largest international law firm presences in Romania, its approximately 40 lawyers covering all areas of commercial and civil law.

With over 8 years of experience in dealing with legal life sciences matters, including corporate and competition laws-related, Lucian Bondoc leads Salans’ Bucharest’ life sciences team. Lucian Bondoc has assisted on a wide range of legal issues to pharmaceutical companies and health companies, including with respect to mergers, tenders, licenses and authorizations, competition law investigations, pricing, advertising, warehousing, clinical trials, hospitality, sponsorship, internal compliance policies, data protection, legal changes, etc.

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IDRAC DATABASE: CONSULTANTS – RUSSIAN FEDERATION

ALMEDIS
Aligned Medical Services
7, M.Novikova str,
123098, Moscow
RUSSIAN FEDERATION

T:+ 7 499 248 0850
F:+ 7 499 248 1972

W:almedis.ru
E:info@almedis.ru

Dr. Maria Nassonova E:maria.nassonova@almedis.ru

ALMEDIS is a contract research and consultancy organization with operations all over Russia.

ALMEDIS PROVIDES:

- Comprehensive support in international clinical trials management and their execution

- Trial design and medical writing, project management and monitoring, data management and biostatistics for local clinical trials

- Regulatory affairs including review and preparation of all documentation in accordance with local requirements and submission

- Consultancy in medical marketing , scientific medical support in promotion & advertising of pharmaceutical products

- Training for company personnel (Regulatory Affairs and Pharmacovigilance specialists, Clinical Research Associates, Medical Representatives etc).

We provide the tailored solutions to meet the requirements of each client and to turn our comprehensive knowledge and experience into our clients’ competitive advantage.

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IDRAC DATABASE: CONSULTANTS - SLOVAKIA

Tatiana Mazancová
Grosslingova 71,
811 09 Bratislava
Slovak Republic

T:00421 2 44 63 26 68
M:00421 907 791 032
F:00421 2 44 63 26 67

E:tatiana.mazancova@gmail.com

Our priority is the successful resolution of our client’s problems, no matter how complex they may seem to those concerned. For this reason we cooperate with the highest quality external consultants.

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IDRAC DATABASE: CONSULTANTS - SLOVENIA, CROATIA

Medi.Si Consulting-Svetovanje
Jelena Kolosnjaj s.p.
Ilot 22 Bat D 2e gauche
Rue de Belfort
61100 Flers
FRANCE

T:+33 6 68 06 16 48

Jelena Kolosnjaj Tabi, MPharm
E:kolosnjaj@gmail.com

Medi.Si Consulting is a company specialised in translation of medicinal documents and in drug regulation in Slovenia, Croatia, Serbia and Bosnia and Herzegovina.

Apart from the regulatory and legal advice, we offer the translation of texts with medicinal content from/to English, French and Italian to/from Slovenian, Croatian, Serbian and Bosniac language.

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IDRAC DATABASE: CONSULTANTS - SOUTH AFRICA

J & B Pharmaceutical Consultants
PO Box 25395
MONUMENT PARK
0105
SOUTH AFRICA

T:27 (0) 12 347 1392
F:27 (0) 12 347 7687

Joy van Oudtshoorn – Eckard
E:joyvo@icon.co.za

J & B Pharmaceutical Consultants specialise in human and veterinary pharmaceutical matters, such as:

- Scientific support for patent matters

- Pharmaceutical product development and production trouble shooting

- Bioavailability studies and clinical trials, advice, placement, management and monitoring

- Regulatory Affairs and related training.

The CEO is Prof Bosch van Oudtshoorn. He studied pharmacy and completed post-graduate studies at the University of Potchefstroom. He studied for his doctorate at the Universities in Zurich and Leiden and was appointed as Professor and head of the Department of Pharmacy at the University of Potchefstroom in 1967.

He was the Executive director of Research and Development of South African Druggists, for many years and is the author and co-author of more than 100 scientific publications and two text books, Medicinal Plants of South Africa and Poisonous Plants of South Africa. He is the holder of several international patents in the field of medicine and member of various statutory and professional bodies.

Joy van Oudtshoorn-Eckard is Executive Director, Scientific and Medical Affairs. She is a pharmacist with post-graduate training in industrial pharmacy who has extensive industry and health authority, regulatory and quality control experience in South Africa and Zimbabwe.

She participates in many MCC and Industry workshops and represents the PMA on the Industry Task Group liaison with the Medicines Control Council. As chairman of the Registration and Bioavailability Specialist Group of the Committee for Science and Technology of the PMA for many years, together with other members of her group, met on several occasions with the Pharmaceutical Committee of the Medicines Control Council, to present and participate in scientific discourse regarding various regulatory matters. She has organised a number of workshops and symposia for the industry.

She is the author of the chapter “Registration in South Africa” in ‘’International Pharmaceutical Registration’’ edited by A Chalmers, designer and author and also responsible for the “registration and control of pharmaceutical products” module of the honours BSc Pharmacy degree of Potchefstroom University.

She is a member of Special interest groups of International Federation of Pharmacists (FIP) and co-author of two of the Herbal Special Interest group publications and serves on the American Association of Pharmaceutical Scientists, (AAPS) Globalization Task Force - an initiative to reach out to pharmaceutical scientists.

She headed the Medical Department of Ciba-Geigy, being responsible for regulatory affairs, clinical research, pharmaceutical product development, medical/marketing liaison, information services, and drug safety for the speciality, generic, self-medication and vision care divisions preceding the consulting activities.

She is an honorary lecturer in pharmaceutics at several Universities. She is also a well known Church Organist.

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IDRAC DATABASE: CONSULTANTS - SPAIN

Ágora Farmacéutica S.L.
c/ Juan Hurtado de Mendoza, 9 -809
28036 Madrid
SPAIN

T:+34 91 359 3079
F:+34 91 345 2518

Helena Torrent
E:agora@agorafarmaceutica.com

ÁGORA FARMACÉUTICA, S.L., is an independent Regulatory Consulting Company, established in Madrid (Spain) since 1995 to cover a wide range of Regulatory Affairs and Consultancy services for the Pharmaceutical and related Healthcare Industries. Our activity is mainly focused on Regulatory Affairs, including the preparation of CTD dossiers for Registration through National, Mutual Recognition or

Decentralized Procedures to obtain Marketing Authorizations of Human, Veterinary, Cosmetic and Food products, as well as Medical Devices or Herbal products.

We advise our clients on the best approach to obtain Marketing Authorization for their products and to maintain them through the preparation of Variations, Renewals, Labelling Readability tests, Expert Reports…). We prepare Pricing and Reimbursement Procedures and offer Pharmacovigilance services.

Our regulatory activities also include the submission of clinical trials, amendments or specific documents either to Ethical Committees or Health Authorities.

We advise on the preparation and submission of Applications for Storage, Importation or Distribution of products to the Spanish Market.

We also have a qualified translators specialized in Health and scientific translations.

Agora acts as liaison between companies located outside Spain and the local Authorities being an important local link aimed to fulfil the needs and understanding of our clients.

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IDRAC DATABASE: CONSULTANTS - SWITZERLAND

MEDIUS AG
Neue Bahnhofstrasse 160
CH-4132 Muttenz
Switzerland

T:+41 61 465 70 40
F:+41 61 465 70 41

Urs Rickenbacher, Ph.D.
E:rickenbacher@medius-ag.ch

Thomas A. Keller, Ph.D.
E:thomas.keller@medius-ag.ch

W:medius-ag.ch

Medius is a consulting and service company engaged in regulatory affairs of pharmaceuticals, medical devices and other healthcare products. Founded in 1997 by Urs Rickenbacher, Ph.D., the company located in the Basle area has for mission to provide optimal regulatory support for their national and international clients.

Our services include: full service in relation to submissions of marketing authorization applications of pharmaceuticals, life-cycle management of existing products (variations, revisions, re-labeling), expert reports on pharmaceutical, toxicological and clinical issues, conformity declaration of medical devices, reimbursement applications, and regulatory training programs.

We provide specialized consulting in the following areas: development of new active ingredients, development of variations for existing products, development of generic compounds, review of promotion material according to relevant law, evaluation and classification in the process of conformity declaration of medical devices, evaluation of borderline products (cosmetics, specialized food, complementary medicinal products), liaising with authorities.

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IDRAC DATABASE: CONSULTANTS - TURKEY

ZEINCRO MEDIKAL ARAŞTIRMA VE DANIŞMANLIK A.Ş.
Büyükdere cad. Çayırçimen sok.
Emlak Blok. A2 Kat:8 Da.:35
Levent 34330
İstanbul
TURKEY

T:+ 90 212 324 34 10
F:+ 90 212 324 34 12

Mr Cem Murat Eroğlu
E:meroglu@zeincro.com

Ms. Lale Özturanlı
E:lozturanli@zeincro.com

W:zeincro.com

Zeincro Turkey is established in Istanbul as a full-service CRO and consulting office. Our clients include local and multinational pharmaceutical companies, collaborating CROs and medical centers.

WE PROVIDE:

- Clinical trial design and monitoring (Phase I – IV)

- Bioequivalence studies, design and monitoring

- Regulatory affairs and regulatory strategy

- Business development, licensing-in and licensing-out products

- Pricing, reimbursement and market access services

- Training services, organization of seminars

- Data management, biostatistics

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IDRAC DATABASE: CONSULTANTS - UKRAINE

Ms. Natalia Melnikova
Director of Healthcare Regulatory Services Ltd.
Borysohlebskaya str. 9/15, office 27
04070, Kiev,
UKRAINE

T & F:+38 044 467 51 82
Cell1:+38 067 408 70 28
Cell2:+38 050 300 74 00

E:info@regmed.com.ua

W:www.regmed.com.ua

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