- Marketing Authorisation Applications for medicinal products (new active substances, known substances)
- Maintenance of Marketing Authorisations / follow-up (variations, renewals)
- Compilation of Marketing Authorisation documentation
- Advice on submission strategies
- Evaluation of European Marketing Authorisation documentation regarding specific Swissmedic requirements
- Project / submission management (incl. monitoring of deadlines and communication with Swissmedic and headquarter)
- In-house compilation of eCTD sequences for submission to Swissmedic
