Authoring, reviewing, approving and tracking documents that are destined for global regulatory submissions can be a challenge. RAAJ GPRAC team across multiple departments collaborate effectively to ensure that timelines and agency commitments are met. we have an incomparable expertise in filling and filing of dossiers and DMF.

• Dossier writing from Module 1 to Module 5 for generic and new drug application [IND, NDA, ANDA, BLA].
• DMF Application, Covering/Transmittal Letter preparation and review
• 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.
• Assistance in timely Query-Response to the Regulatory Agencies – Review of queries, timely correspondence with agencies, discussion, planning and follow-up with the clients.
• Response preparation and timely submission of query responses to health authorities.