Regulatory & EC Submissions

Clinical trials in Europe must be conducted in compliance with ICH, GCP, the European Clinical Trial Directive and local regulatory requirements. The complexity and diversity of these regulations in the different European member states require in depth knowledge of the specific requirements in each country.

Our dedicated CTA’s have the experience and knowledge to prepare your regulatory packages of essential documents and manage submissions to regulatory authorities and local Ethics Committees in a timely manner ensuring a fast study start-up from phase I till phase IV.