Regulatory Affairs
Regulatory requirements in Europe are continually evolving and further more vary from one country to another. Our regulatory and clinical teams have extensive experience of the different activities required across European countries in order to undertake clinical trials in line with national guidelines.
Our Services include:
- Understanding and interpreting the ever changing regulatory environment
- Preparation and submission of clinical trial submissions
- Conduct of Post-Authorization Safety Studies (PASS), non-interventional/observational studies, registry studies
- 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
How can we help?
Contact our team of experts for more information.