Regulatory Affairs in Clinical Research

How we manage clinical study applications in Europe

The regulatory landscape in Europe has become even more complex and requires specialists who know how to manage the application processes of different study types and product classes. We feel at home in the European legislation on clinical studies with medicinal products and medical devices, as well as in the national legislations. Based on your specific needs, we develop application dossiers that satisfy all relevant criteria. Our team interacts with the national and local regulatory authorities, as well as with ethics committees and institutional review boards in a coordinated effort to fulfill the regulatory requirements to conduct your project.

Your navigator through the regulatory meshwork

At FGK we are always up to date with the current regulatory requirements in Europe. We efficiently navigate your project through the complex meshwork of European regulations and guidelines and ensure compliance with the applicable international standards, e.g. ICH-GCP, ISO 14155 or ISO 20916.

Our support after clinical study approvals

Moreover, having created your successful clinical study application, FGK regulatory professionals support your project throughout its lifecycle and take care of the preparation and submission of amendments and notifications. With our regulatory advice, we help you to keep your project on track.

What we do in the Regulatory Affairs department

  • We know the latest European legislation and guidance documents, and the peculiarities of different regulatory requirements spanning the whole continent
  • We develop protocols, patient information sheets and informed consent forms, product labels and other study documents
  • We communicate with national competent authorities, ethics committees, further involved regulatory bodies and insurance companies
  • We submit application dossiers and updated information to the European Clinical Trials Information System, as well as to national competent authorities and ethics committees
  • We keep records of all regulatory steps, relevant correspondence and applicable documentation