Regulatory Affairs
Competent submission of clinical trials in Switzerland.
Our experienced Regulatory Affairs team supports you in submitting clinical trials and research projects in accordance with the Human Research Act (HRA) and the corresponding ordinances. We accompany you through all phases of the approval process - from dossier preparation to communication with the authorities.
Our services
- Project-specific dossier compilation - submission and category-specific
- Submissions to ethics committees and Swissmedic - applications, modifications, safety and other reports
- Coordination and communication with authorities (incl. processing of approvals and conditions)
- Trial registration in national(Human research in Switzerland) and international registries(ClinicalTrials.gov)