Local regulatory environment knowledge is crucial for any medical research.. Timing and proper handling of the documents open the way to start.
We know the role of each department and how they work to reduce rejections and delays.
- Initial Application, preparation for Ethics Committee
- Initial application file preparation for Regulatory approval
- Follow-up of applications
- Preparation of files for regulatory and administrative changes during study
- Pharmacovigilance reporting to EC’s and Regulatory Authority
- Applications to RA for site coordinators
- Institutional review board