Marketing Authorization
We compile and submit your registration documents to Swiss, European and US American (Health) Authorities, e.g.:
- Site Master File (SMF)
- Drug Master File (DMF)
- Active Substance Master File (ASMF)
- Certificate of Compliance to the European Pharmacopoeia (CoS)
- Investigational Medical Product File (IMP File)
- Technical Documentation / IND
- Common Technical Documentation (CTD)
Upon your request, we comprehensively take care of your entire application realizing all contacts and agreements with the competent authorities.