Regulatory Affairs
Switzerland
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 EU or FDA dossiers to the local requirements of Swissmedic
- Electronic submission of the dossier (eGov Swissmedic portal)
- Ongoing supervision and finalization of the registration process
- Management of the life cycle of the medicinal products
- Request for Company meetings at Swissmedic (i.g. scientific advice, pre-submission meeting)
For medicinal products already authorized in another country with a comparable approval system as Switzerland, Swissmedic offers a simplified approval processes (Art. 13, Art 14, Bst 1 abis). 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.
International
In collaboration with our partners regulanet®, Target BioScience supports you in international marketing authorization applications in the European Union countries.