Bringing a new product from development to marketing approval is an expensive and lengthy process. If unanticipated delays occur, costs in both time and money can rapidly escalate. Scope International provides full regulatory support for clinical studies (clinical trials as well as non-interventional studies (NIS)) at any stage in the process.
Our project managers work closely with our regulatory affairs department to ensure all areas of your clinical study meet international and local regulatory standards.
Thorough but fast, our regulatory experts cut out delays and help reduce costs.
Contact our regulatory affairs unit for expert guidance.
- Advice on regulatory procedures
- Preparation and submission of initial applications and substantial modifications under involvement of our local study teams
- Local accompanying of the approval process and communication with competent authorities as well as ECs/IRBs and other parties
- Study management, including substantial and non-substantial amendments, notifications and periodic reporting (non-safety and safety via Pharmacovigilance)
- Reporting, notification for information during and after the clinical study
- Import/export licenses (incl. narcotics and psychotropic drugs)
- Support in entering information in registry platforms and databases (incl. result disclosure)