FGK Representative Service GmbH
Biotechnology
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Short facts
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- Research & Development
- Service Provider
- Year founded 2004
- 8 Employees (site)
- Turnover: <5m EUR
Products/services: FGK Representative Service GmbH was founded in order to meet legal requirements of sponsor companies which do not have a subsidiary within the European Union (EU) and Switzerland, for the purpose of performing clinical research projects in the EU. Such a representative, known as a “legal representative” for clinical drug trials and “authorized representative” for medical device trials, fulfills the obligation that the drug and the medical device companies must be established or represented in the EU.
Basic data
Company
FGK Representative Service GmbH
Street
Heimeranstr. 35
PC / City
80339 München
County
Upper Bavaria
Phone
+49 89 893119-0
Fax
+49 89 893119-20
Homepage
Language skills
English, German
Contact person
Management: Dr. Edgar J. Fenzl (Mr.)
Profile/competences
Core competencies
FGK Representative Service GmbH was founded in order to meet legal requirements of sponsor companies which do not have a subsidiary within the European Union (EU) and Switzerland, for the purpose of performing clinical research projects in the EU. Such a representative, known as a “legal representative” for clinical drug trials and “authorized representative” for medical device trials, fulfills the obligation that the drug and the medical device companies must be established or represented in the EU.
The Clinical Trials Directive (2001/20/EC) requires that for all clinical drug trials in the EU a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area. The various
member states have implemented this Directive into regulations that apply within each territory separately.
Key sectors / sub-sectors
- Biotechnology: Contract research (CROs) and contract manufacturing (CMOs)
Certifications
not available
Sales markets - target industries
not available
Sales markets - target countries
Canada, China, Israel, Switzerland, United Kingdom, United States
Cooperation offers
not available