Regulatory Affairs

Regulatory requirements are continually evolving and further more vary from one country to another. To get the right strategy and moreover the different activities required across European countries in order to undertake clinical trials in line with national guidelines, our regulatory and clinical operation teams have extensive experience. Whether the internal experts or external cooperation partner for dedicated countries, both will cooperate together and guide the client to have all necessary documents together – on time.

Our Services include:

  • Understanding and interpreting the ever changing regulatory environment
  • Preparation and submission of clinical trial submissions
  • Interaction with regulatory agencies world-wide
  • Preparation of country-specific documentation and submissions
  • Preparation of end-of-trial declarations
  • Preparation & submission of medical device trials