Regulatory Affairs


Target BioScience provides regulatory services for the application and maintaining of marketing authorization of medicinal products at Swiss Agency for Therapeutic Products Swissmedic:

  • Preparation and submission of marketing authorization application
  • Adaptation of dossiers (eCTD or CTD paper) to the requirements of Swissmedic
  • Submission of the dossier
  • Ongoing supervision and finalization of the registration process
  • Management of the life cycle of the products
  • Application for scientific advice at Swissmedic

For medicinal products already authorized in another country with a comparable approval system as Switzerland, Swissmedic offers a simplified approval process. We prepare marketing authorization application for your medicinal product to fulfil Swissmedic requirements for simplified or for standard submission to receive marketing authorization in the shortest possible time.

We understand the unique regulatory requirements for orphan drugs and offer unique solutions to your challenges.


In collaboration with our strategic partner Dr. Regenold GmbH and/or regulanet, Target BioScience supports you in international marketing authorization applications in the European Union countries.