FGK Representative Service GmbH

Company

    • Company type:
      • Research & Development
      • Service Provider
    • Year founded:
    • 2004
    • Employees (at the site):
    • 8
    • Turnover range:
    • <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.

    • 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.

    • Language skills:
    • Chinese
      Czech
      Dutch
      English
      French
      German
      Hungarian
      Italian
      Polish
    • Key Tech / section:
      • Biotechnology: Contract research (CROs) and contract manufacturing (CMOs)
    • Certification:
    • not available

    • Sales markets - target industries:
    • not available
    • Sales markets - target countries:
    • not available
    • Cooperation offers:
    • not available
    • Contact person:
    • Dr. Anthony W. Fox (Mr.)
      - Management

      Dr. med. Edgar J. Fenzl (Mr.)
      - Management