We are ISO 21001 : 2018 Certified
API/EXCIPIENTS
- 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].
- CEP & CoS (Certificate of Suitability to the monographs of European Pharmacopoeia) submission to EDQM
- APIMF (WHO), MF (PMDA, Japan) and emerging markets DMF
