Documentation

  • Dossier writing from Module 1 to Module 5 for generic and new drug application [IND, NDA, ANDA, BLA].
  • Quality Module 3- CMC and Scientific Writing
  • Critical Review of Dossier and Preparation of GAP Analysis Report
  • Existing dossier suitability to new market (Gap analysis and solution
  • 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.