Regulatory affairs

How we manage application processes in Europe

European ethical oversight and regulatory bodies are nowadays very intricate, and clinical trial approvals therefore require bespoke documents as well as people who know how to manage the application process. Our team interacts not only with the international, national and local regulatory authorities, but also with ethics committees and institutional review boards. This type of coordinated effort is necessary for fulfilling the regulatory requirements to conduct your clinical trial.

 

Your navigator through the regulatory meshwork

At FGK we are always up to date with the most recent regulatory requirements. We efficiently navigate your project through the complex meshwork of regulations and guidelines (many of which are de facto regulations if you wish to avoid delay) and ensure compliance with the international standards, e.g. Good Clinical Practice (GCP) by the International Conference on Harmonization (ICH).

Our support after clinical trial approvals

Moreover, having created your successful clinical trial application, FGK regulatory professionals support your project throughout should the need arise, whether it involves amendments, notifications, periodic reporting or regulatory advice.

What we do in the Regulatory Affairs department

  • We communicate with competent authorities, ethics committees, local authorities, insurance companies
  • We know the latest legislation and guidance documents, and the peculiarities of different regulatory requirements spanning the whole continent
  • We develop protocols, informed consent forms, drug labeling and other study documents
  • We submit application dossiers, updated information, expedited and periodic safety reports to competent authorities and ethics committees
  • We keep records of all regulatory steps, particular correspondence and applicable documentation