DMF,ASMF,KDMF,CEP/CoS

  • CEP/CoS (Certificate of Suitability to the monographs of European Pharmacopoeia) submission to EDQM
  • US-DMF [Type II Drug Master File review and writing in ICH-M4Q format], Active Substance Master File (ASMF)-EU, KDMF (Korean), DMF Type III & Type IV [ Excipients & Packaging materials].
  • APIMF (WHO), MF (PMDA, Japan) and emerging markets DMF