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 (CEP)
  • 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.