We offer services to cover your regulatory needs:
- Protocols, Clinical Study Reports (CSR), Common Technical Document (CTD) modules
- Database Search and Literature Reviews
- Clinical Evaluation Reports (CER) for medical devices
- Investigator’s Brochure (IB), Investigational New Drug (IND), New Drug Application (NDA)
- CMC modules
and beyond, we are with you every step of the drug development cycle, whatever the therapeutic area.