Regulatory Affairs

  • 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