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.