Consultant List

IDRAC DATABASE: CONSULTANTS – SERBIA

Experta Consulting
Agency for consulting and services in toxicology and pharmacy

Nehruova 57
11070 Belgrade

T: +381117179560
T: +381638787177
T: +38765956218
W: http://www.experta.co.rs
E: expertaco@gmail.com

Professor Milan Jokanovic, PharmD (Tox)

E: milan.jokanovic@gmail.com

Experta Consulting provides valuable services in the field of pharmaceuticals:

Registration of medicines, pharmaceutical products and medical devices in Serbia and Bosnia and Herzegovina.
Preparation of full dossiers, toxico-pharmacological and clinical expert reports, Summary of product characteristics (SmPC), Patient information leaflets (PIL), Periodic safety update reports (PSUR), and Other Documentation Required For Registration of Human and Veterinary Medicines, Medical Devices and Traditional Herbal Medicines. The registration files can be prepared under EU-CTD format either in English or Serbian language.
Review of documentation transferred from foreign pharmaceutical companies to local representative partners, preparation of application forms and other necessary documentation in Serbian language for regulatory submissions to Medicines and Medical Devices Agency of Serbia (ALIMS). Professional translation of SmPC and PIL to Serbian language.
Preparation of documentation required for registration of medical devices. Preparation of protocols, conduct and reporting of nonclinical studies related to medical devices.
Preparation of preclinical drug development programs and protocols. Monitoring of preclinical drug development studies.
Protocol design and monitoring for Bioequivalence studies. These studies are performed according to Good Clinical Practice and Good Laboratory Practice Standards in certified clinics and laboratories in Serbia according to the highest scientific standards.
Monitoring clinical drug trials.
Consultancy to pharmaceutical companies related to design and evaluation of R&D Programs.
Medical writing including writing scientific reports and literature review reports related to drugs and chemicals, writing publications for scientific journals and presentations for meetings. Preparation and independent evaluation of internal reports.
Liaisons with Medicines and Medical Devices Agency of Serbia in Belgrade and Agency for Medicines and Medical Devices of Bosnia and Herzegovina in Banja Luka.

IDRAC DATABASE: CONSULTANTS – UKRAINE

Oleksandr Matvieiev, MD, PhD
Crimea, Simferopol
Lenina blvd 5/7
Crimea State Medical University
Department of Clinical Pharmacology and Pharmacotherapy
UKRAINE

T: +380 65 234 74 33
M: +380 50 914 29 38
E: avmcsmu@gmail.com
W: http://prlz.com.ua/

Oleksandr Matvieiev is Assistant Professor of Clinical Pharmacology and Pharmacotherapy Department.
He specializes in Pharmacovigilance, Clinical Trials and Evidence-based Medicine.
He is a member of Ukrainian Association of Pharmacologists, International Society of Pharmacovigilance (ISoP) and International Society of Pharmacoepidemiology (ISPE).
He is also a member of local Bioethics committee which performs the expertises of ethical aspects of clinical and experimental investigations.

IDRAC DATABASE: CONSULTANTS – PHILIPPINES

QAFM SERVICES
5580 Kimmeridge Gate
Mississauga, Ontario
L5M 6B3 CANADA

T: +1 905 819 0386
M: +1 647 273 7609

Mr. Salvador Y. Funcion, BSCHE, MBA, CQA
E: syfuncion@yahoo.com

QAFM SERVICE is a Canadian and Philippine based regulatory consulting business with a broad background in regulatory affairs compliance, quality management systems and audits.

The principal consultant has over 19 years experience in the medical drugs, devices, food, nuclear power generation and chemical industry, and relevant experience of working in the Philippines, US and Canada.

QAFM’s services extend from conceptual development through to regulatory support, quality management and manufacturing. QAFM delivers innovative, market appropriate and technically sound regulatory compliance solutions. One of the most valued services to our clients is the direct support during Regulatory or 3rd party audits, including preparing reports and providing advice that is crucial to having successful regulatory audits conducted by the US FDA, Health Canada or Philippine FDA. QAFM provides audit preparation, training and consulting.

Consulting services include:

Infrastructure development (Quality Manual, SOPs and Working Practices Creation and Review)
Electronic Document Control System Creation
Corrective Action and Prevention System (CAPA) maintenance
Follow-up Process
Training and Qualification Program
Medical Drug and Device Application
Dossier review- gap analysis reports

IDRAC DATABASE: CONSULTANTS - NORWAY

LINK Medical Research AS
Gjerdrumsvei 16
0484 Oslo
Norway
www.linkmedical.no

T: +47 22589000
F: +47 22589001
E: link@linkmedical.no

Michelle Lindøe Enger, Acting Director of Regulatory Affairs & Pharmacovigilance
E: michelle@linkmedical.no

LINK Medical Research is a Scandinavian CRO, offering a broad range of clinical development capabilities, consulting on regulatory affairs, and services such as health economics, pharmacovigilance and quality assurance.

LINK assist in the preparation, assembly, validation and submission of Marketing Authorisations Applications and are experienced in drug development and validation of regulatory documents. LINK has a regulatory department made up of 12 dedicated professionals and with significant experience in the following areas:

Regulatory Affairs & Pharmacovigilance
http://linkmedical.no/uploads/dokumenter/Regdocument2010-09-13-110126.pdf

Preparation, assembly, validation and submission of Marketing Authorisation
Variations, renewals & transfer of Marketing Authorisation
Translations
Updating Summary of Product Characteristics (SPCs), labelling texts and package leaflets, Proof-reading artwork
Catalogue texts e.g Felleskatalogen
User/readability testing of package leaflets
Pharmacovigilance and Risk Assessment
Adverse event management, Electronic reporting
Annual safety reports & Periodic Safety Update Reports (PSURs)
Literature searches
Registration with EudraVigilance
GMP, GDP, GCP, GLP
Pricing and reimbursement
Procedure for applying for Manufacturing Authorisation
Definition of Medicinal Products
Cosmetics/Herbal medicines, Medical Device
Providing regulatory advisory services
Assessing the suitability of your documentation
Establishing product development plans for the pharmaceutical development phase, the pre-clinical phase and/or the clinical phase
Preparation of pre-submission meetings and scientific advice

Biometrics

Data management
Statistics
Medical writing
Health economics http://web2134.increo.no/uploads/dokumenter/Health%20economy%20flyer%202010-09-13-110244.pdf

Quality Assurance
http://linkmedical.no/uploads/dokumenter/QAdocument2010-09-13-110201.pdf

Quality Systems

IDRAC DATABASE: CONSULTANTS - EGYPT

Quadri Pharma
20 Dr. Mahmoud Azmy St.
P.O Box 133 Zamalek , 11211

E: quadri@link.net
T: (202) 27355830 - 27356707
F: (202) 27357410

Mission: Provision of technical back-up services simulating those arising from direct presence of any given company through its own subsidiary or regional set up.

Regulatory Affairs:

International Pharmaceutical Companies
Registration, Pricing & Administrative services aiming at compliance and adaptation with local requirements
Contract Research Organizations "CRO's"
Selection of Sites
Securing Needed Protocol Approvals
Handling MOH Relevant Logistic Procedures
Adequate Translation to Local Language

Medical Support:

Monitor of Phase II / III clinical studies for registration purposes
Phase IV marketing oriented clinical trials (PMS)
Co-ordination of Product Related Regional / International multi-center studies conducted at institutions of Quadri Territories.

Marketing support:

Market surveillance on therapeutic group / individual product basis.
Product pre-registration & /Or launch planned activities.
Market plan design, action plan details & it's implementation monitor.
Direct involvement in KOL conventional promotion activities (Satellite Missions).
Organization of Local / Regional unconventional activities (Symposia, Road Show Lectures, etc)

Regional Activities liaison:

Provision of all or any selection of services at all &/Or selected country gp basis
Monitor of performance of appointed sub- distributors
Securing uniformity of addressed strategy and message of our "Principals" wherever represented
Provision of "Product Training" to assigned local sub-distributor staff

IDRAC DATABASE: CONSULTANTS - VENEZUELA

IntegraMed Consulting
Maria C Torres-Moore MD
Chicago, IL. US

E: torrescristi@gmail.com

International Regulatory consultant and a Pharmaceuticals and medical devices consultant for Latin America.

More than 20 years of experience in the Pharmaceutical field. Providing Regulatory affairs consulting from the office based in the US, with a network with Latin American consultants.

In Venezuela,
Peggy C Casanova D. Pharmacist, MSc.
Av. El Sol. Qta Peralu. Sta Paula
Caracas 1061
Republica Bolivariana de Venezuela.
T: (58) 424-1535885
E: peggycasanova@yahoo.es

Offers product and services consulting in regulatory environment. Expertise in Regulatory topics, quality assurance, pharmacovigilance and clinical research.
Current and past activities include, member of USP STEP - Spanish Translation Expert Panel - working in the pharmaceutical industry as responsible for product registration, pharmacovigilance, registration of clinical studies. Registration of Devices, food products and cosmetics.
Member of teams for Biologics, Food, Vitamins and minerals.
Worked with PAHO as a Consultant in Medicines.

IDRAC DATABASE: CONSULTANTS - PERU

ASESFARM SAC
Psje. Los Guayaquiles 328,
Urb. Micaela Bastidas. Distrito Los Olivos – Lima,
PERÚ

T: 511-7958383
T: 511-995326572
T: 511-971156238

W: http://www.asesfarm.com/
E: informes@asesfarm.com

Ms. Giovanna Llanos Rebaza
E: gllanos@asesfarm.com

Mr. Elvis Leyva Minaya
E: eleyva@asesfarm.com

ASESFARM SAC is a service company that provides consulting and training in Regulatory Affairs and Quality Management in pharmaceutical establishments.

Our commitment is focused on achieving customer satisfaction, attending a timely manner and effective their needs, allowing us to become strategic partners to achieve their goals

We are a company with innovative spirit, with highly trained, service oriented and seeking continuous improvement and continuous development.

The services ASESFARM SAC provides are:

Procedures for obtaining the marketing authorization (sanitary registry) of pharmaceuticals and related to the DIGEMID.
Advice and technical support to pharmaceutical establishments (such as BPA, GMP, etc.).
Modifications, update, renewals and others procedures the marketing authorization (Sanitary Registry) requested by the marketing authorization holder or for authority.
Translation of technical documents
Review technical documents (validations, stability studies, analytical methods, safety and efficacy studies) to be submitted to the authority under existing rules.
Obtaining Trademarks and Patents.
Advice on Implementation of Quality Systems (ISO)
ASESFARM acts as a liaison between companies located outside of Peru and local authorities to collaborate on the diverse needs of our customers.

SFARM acts as a liaison between companies located outside of Peru and local authorities to collaborate on the diverse needs of our customers.

IDRAC DATABASE: CONSULTANTS - FINLAND

Farenta Oy (Ltd)
Дyritie 16
FI-01510 Vantaa
Finland

T: +358 104398233
F: +358 102960737
E: farenta@farenta.fi
W: www.farenta.com

Farenta is a full range service provider for the pharmaceutical industry in Finland and Nordic countries.

Our main business fields are pharmaceutical staffing, recruitment, training and expert services for the pharmaceutical industry and pharmacies. At the moment, we are the second largest pharmaceutical employer in Finland with more than 400 employees. We also offer Farenta Net, a communication channel that allows the flow of data between pharmacies and the industry. At Farenta, your data is always safe, our highly secure IT system enables the protected transfer of information between our customer and us.

Our main areas of competence are:

Regulatory affairs services
Pharmacovigilance
Pricing and reimbursement services
Research services
Translations
Drug wholesale license support
Sales and marketing services

IDRAC DATABASE: CONSULTANTS - ARGENTINA, CHILE, COLOMBIA

Telstar - Life Science Value Services
Av. Del Libertador 6550, 2B, C1428ARV - Ciudad de Buenos Aires ARGENTINA

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

Mrs. Vanesa Skredzelewski
E: vanesa.skredzelewski@telstar.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).

IDRAC DATABASE: CONSULTANTS - ASEAN, HONG KONG, MALAYSIA, SINGAPORE, and INDONESIA

Theorem Clinical Research

T: +49 6196 5228 353
F: +49 6196 5228 155
W: http://www.theoremclinical.com/

Barbara Dogan
E: Barbara.Dogan@theoremclinical.com

RIGHT FROM THE START, RIGHT TO THE END

Are you looking for reliable regulatory consulting that works diligently for you? At Theorem 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. Theorem 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 Theorem 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 Theorem Clinical Research.

READY TO DELIVER

Experience ensures readiness for any challenge. Theorem 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

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

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

DOKUMEDS, SIA
Alojas iela 6
Riga, LV-1013
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: http://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

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

Isabel Vande Velde
E: Isabel.VandeVelde@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.

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.

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.

IDRAC DATABASE: CONSULTANTS - CANADA

OptumInsight
4 Innovation Drive
Dundas, Ontario
L9H 7P3
CANADA

T: (905) 689 3980
F: (905) 689 1465
W: http://www.canreginc.com

Ms. Anne Tomalin
E: anne.tomalin@optum.com

OptumInsight, previously 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.

IDRAC DATABASE: CONSULTANTS - DENMARK

Jacobsen Pharma A/S
Nørre Havnegade 108
DK-6400 Sønderborg
DENMARK

T: +45 74441936
F: +45 74441937
E: info@jacobsenpharma.dk

Anette Jacobsen, Managing director, M.Sc.Pharm
E: anette@jacobsenpharma.dk

Regulatory affairs specialists in Scandinavia and EU. Members of EUDRACON and TOPRA. We offer support on:

Marketing authorisations
New applications, variation application procedures and renewal procedures
Medical writing and translations
Medical translations and Medical writing
eCTD
We can offer to prepare documentation for registration dossiers eCTD format. This may be relevant for new registration dossiers or in connection with variations.
Pharmacovigilance
A complete solution, adverse event receipt and reporting, pharmacovigilance system, Eudravigilance registration and risk management
Development management
Review of in-licensing products, Product acquisition and development, Choice of contract manufacturer, Product registration strategies and Strategic regulatory consulting
Wholesale dealer's licences
We can assist your company in obtaining or renewing wholesale dealer's licenses in Denmark. We can provide quality systems customised to the needs of your company and we can perform pre-inspections preparing your company for an authority inspection.
Wholesale dealer's licences
We can assist your company in obtaining or renewing wholesale dealer's licenses in Denmark. We can provide quality systems customised to the needs of your company and we can perform pre-inspections preparing your company for an authority inspection.

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: http://www.deavinassociates.co.uk

IDRAC DATABASE: CONSULTANTS - FRANCE

A.R.C. Pharma
41 rue de Villiers
92200 Neuilly-sur-Seine
FRANCE

T: +33 1 47 59 87 87
F: +33 1 47 59 87 88
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.

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.com

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.

IDRAC DATABASE: CONSULTANTS - GREECE

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

T: +30 210 8047709
F: +30 10 6134695
W: http://www.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

IDRAC DATABASE: CONSULTANTS - GCC (GULF COOPERATION COUNCIL), SAUDI ARABIA

NIBRA Consultancy Center is an emerging company providing state of the art consultancy services to global pharmaceutical organizations.
The NIBRA Consultancy Center offers a high level of expertise and prudence to support companies who wish to register their company with the Saudi Food & Drug Authority (SFDA), introduce their pharmaceutical products within the Saudi Arabia market, and seek MOH approval for clinics, poly-clinics and hospitals.

Please contact your IDRAC Account Manager for details of our local consultant for GCC and Saudi Arabia.

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.

IDRAC DATABASE: CONSULTANTS - INDIA

Optimus Pharma Consulting

T: +918026636149
M: +919901698708
F: +918026636149

C. Omprakash
E: om@optimuspharmaconsulting.com

Optimus Pharma Consulting provides Business Consulting & Services to the drug and device development industry, specifically focussing on BIOLOGICALS, Vaccines, rDNA products, Small molecules, Biotechnology products, NBE's, NCE's, NME's, Medical devices, Diagnostics, Generics, Biosimilars and Formulations.b>

Integrating Science, Regulations and Measurable Business outcomes, we offer Strategic Consulting and Holistic Service solutions to help customers overcome Business challenges starting from product discovery, product development, to commercialization. We strategize and implement regulatory solutions to ensure project success with a strong ROI.

Our unique approach towards project execution ensures that we meet customer expectations in terms of quality, confidentiality and deliverables and help customers overcome operational problems.

Optimus Pharma Consulting provides regulatory services in the areas of: strategy, study approvals, market authorizations, and post marketing approval, dossier services, regulatory writing and submission management.

Our other services include:

Quality management (creation of study and site SOP's, independent auditing etc), program management (clinical research), clinical analytics (incl. Biostatistics, CRF design, CDASH; SDTM; ADaM), biostatistics, pharmacokinetics, medical writing, and pharma process consulting.

Our overall experience includes over four hundred preclinical, clinical trial(Phase I to IV) approvals, product registrations, marketing authorizations, import and marketing authorizations, manufacturing and marketing authorization transactions covering a large number of therapeutic and product categories.

We assure you of reduced project costs, faster delivery and improved productivity.

For more details please visit our website: www.optimuspharmaconsulting.com

IDRAC DATABASE: CONSULTANTS - THAILAND, VIETNAM

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

T: +65 67373642
F: +65 64713642
W: http://www.gleneaglescrc.com

Dr Anjali
E: dranjali@gleneaglescrc.com

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).

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: http://www.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.

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.

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: http://www.res-servizi.eu - http://www.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

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

IDRAC DATABASE: CONSULTANTS - AUSTRALIA, NEW ZEALAND

Biotech Regulatory Solutions
T: +612 9979 2180
F: +612 9979 2170

Mrs Katy King
E:katy@biotechregulatory.com.au

Biotech Regulatory Solutions is an Australian based regulatory consulting business with a broad background in regulatory affairs, R&D and drug development within the pharmaceutical industry.

The Principal Consultant has over 19 years experience in the pharmaceutical industry and experience working in the UK and Canada. The combined consulting experience within Biotech Regulatory Solutions is 30 years.

We provide the following regulatory consulting services:

- Prescription Medicines – NCE, line extensions, major variations & general maintenance

- Biotech Medicines – NCE, line extensions, major variations & general maintenance

- OTC medicines – NMA, variations & general maintenance

- Medical Devices

- Literature Based submissions

- Dossier review- gap analysis reports

- Orphan Drug Applications

- Import Permit applications

- GMP Manufacturing consulting

- Clinical Trial set-up assistance

IDRAC DATABASE: CONSULTANTS - POLAND

mediReg Pharmaceutical Consultancy
Mr Przemysław Chudy

T: +48 790 500 725
F: +48 22 676 68 12

W:www.medireg.pl
E: pchudy@medireg.pl

mediReg is a regulatory affairs consultancy company operating in Warsaw, Poland. Our knowledge is based on practical experience gained directly in both the pharmaceutical industry and Regulatory Agency, with membership of EMEA groups such as the Mutual Recognition Facilitation Group (currently CMDh) and the Name Review Group. We provide a whole range of high quality services to our customers in the field of medicinal product authorisation and subsequet life-cycle managment such as:

presubmission auditing of dossier for compliance with EU/local requirements
assistance with dossier preparation incl. administrative part, product information, medical writing
supervision of registration process
variation application management
submission of variation application to Competent Authorities with its subsequent supervision
notifications to package leaflets and labeling MAH transfer
renewal application preparation, application submission and supervision
local Pharmacovigilance compliance

Specifically for European procedures (MRP/DCP) we offer:

compliance check against the specific local requirements
submission of application to Competent Authorities with its subsequent supervision
Product Information translation

For more details please visit our website: www.medireg.pl

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: http://www.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.

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: http://www.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.

IDRAC DATABASE: CONSULTANTS – RUSSIAN FEDERATION

Oleg Borisenko, MD, PhD

T: + 7-905-574-66-40

E: olegborisenkomd@gmail.com.ru

Dr. Oleg Borisenko is an experienced consultant in market access, pricing, health economics and healthcare policy.

Dr. Borisenko leads the Laboratory for Quality Management in HealthCare and Evidence-Based Medicine at Department of Standardization in Healthcare of Academic Institute of Public Health and Management in Healthcare at The I.M. Sechenov First Moscow State Medical University (MSMU).

From 2007 to 2011, Dr. Borisenko was the Executive Director of the Russian Society for Pharmacoeconomics and Outcomes Research (RSPOR), and was involved in different projects in the field of health economics, outcomes research and public health.

Dr. Borisenko is a member of the editorial board for the 'Journal of Medical Economics' (Informa), the 'Clinical Pharmacology and Pharmacoeconomics' Journal, and the 'Bulletin of Moscow Academic Therapeutic Society'. He is a reviewer for Cochrane Collaboration; a member of the International Society for Pharmacoeconomics and Outcomes Research, and of the Russian Society for Evidence-Based Medicine. He is a frequent speaker at international and Russian conferences in the field of health economics, reimbursement and funding.

Dr. Borisenko provides an in-depth vision of the Russian and CIS countries healthcare in his Health Economics Blog at www.heblog.info.

IDRAC DATABASE: CONSULTANTS - SLOVENIA, CROATIA

Medi.Si Consulting-Svetovanje
Mrs Jelena Kolosnjaj-Tabi, PhD, MPharm

6 Avenue de la liberté
92000 Nanterre
FRANCE
T: + 33 6 51 39 00 22

UL IX. Korpusa 11
6310 Izola
SLOVENIA
T: +386 41 879 160

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

Medi.Si Consulting is a company specialised in drug regulation in Slovenia, Croatia, Serbia and Bosnia and Herzegovina and in translation of texts with medicinal content (SPCs, notices, MA application forms, translation or summation of scientific articles, user manuals and brochures, etc.) from/to English, French and Italian to/from Slovenian, Croatian, Serbian and Bosniac language.

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.

IDRAC DATABASE: CONSULTANTS - SPAIN

Ágora Farmacéutica S.L.
c/ Juan Hurtado de Mendoza, 9-611
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.

IDRAC DATABASE: CONSULTANTS - TURKEY

ZEINCRO MEDIKAL ARASTIRMA VE DANISMANLIK A.S.
Barbaros Mah. Gülpınar Sok. No:5/1
34746 Ataşehir / ISTANBUL / TURKEY

T: + 90 216 470 00 38
F: + 90 216 470 06 31

Mrs Christina Bratakou
E:cbratako@zeincro.com

Ms. Lale özturanli
E:lozturanli@zeincro.com

W: http://www.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

IDRAC DATABASE: CONSULTANTS - UAE (UNITED ARAB EMIRATES)

PHARMASOLUTIONS

T:+9716 7459313
F:+9716 7459323
M:+97150 5653603
W: www.pharmasolutions-int.com

Mr.Khurshid Zaidi

E: khurshid@pharmasolutions-int.com

Pharmasolutions is a medium sized company engaged in the following activities ( include, but not limited to)

Regulatory services in the region of GCC, particularly in the UAE.
Services include project planning, Dossier consultation and submission. In licensing, Pharmacovigilance etc.
GMP site inspection, stability & Bio-equivalence data validation.
Marketing services include product development planning, pricing recommendation, Competitor activities, Tender price levels, assistance in distribution through a commercial partner.

Principal consultant is a qualified Pharmacist with a post graduate in Business management. Mr.Khurshid has an experience of 15 years in the Pharmaceutical industry, out of which 10 years has been in Regulatory affairs in the region.

IDRAC DATABASE: CONSULTANTS - LEBANON

Clinserv International Group

St. Michael street, Blom Bank Building, 1st floor, PO Box: 116-5262 Sami Solh, Beirut, LEBANON

T:00961 1 275 622
F:00961 1 275 626
W: www.clinserv.net

Mission: To provide high quality clinical research services based on:

Strong international, medical and pharmaceutical knowledge
Long expertise in international clinical trials (American, European and the Middle East)
Compliance with international quality standards ( 21CFR, ICH, GCP and ISO9001) with full respect of local regulations

Services:

Study management and Monitoring (Phase II – IV clinical trials)
Data Management and Statistics
Phase I and Bioequivalence
Medical Writing
Regulatory Affairs
Quality Assurance

Locations: Lebanon, Jordan, Egypt, Saudi Arabia, Syria

IDRAC DATABASE: CONSULTANTS – TAIWAN

Supharm International Corporation

T: + 886-2-22317198
F: + 886-2-29261959
W: http://www.supharm.com.tw

Diane Bai
E: dianebai@supharm.com.tw

Supharm was founded in 1995 to provide the professional regulatory service for the international pharmaceutical company and medical device company to get the approval for the PMF registration, PIC/S GMP certificate, the product license of pharmaceutical preparations, NHI price’s re-imbursement, the QSD registration, the product license approval for the medical device, license holding and sub-authorization for the distributors to sell the products. The aim is to serve for the clients to get the early approval for the certificates and product license with Taiwan Food and Drug Administration in Taiwan.