Submissions and commercialization authorisation/application
CVO-EUROPE specializes in Healthcare legislation, norms and regulations. As a result of the dedication of our experts, combined with the Gxpm REGULATORY DATABASE monitoring tool, our teams are able to offer support and assistance in all regulatory compliance projects.
Our offer
New Drug Application (NDA)
- Auditing/Technical and regulatory evaluation of pharmaceutical documentation
- Preparation of the NDA
- Verification of content completeness and integrity
- Assistance in Application Submissions
Technical and Regulatory documents/eCTD
- Assistance for eCTD setup
- Regulatory Support/Assistance
- Document Management System (DMS) Evaluation and Optimization
- Validation of DMS and eCTD Systems