New Market Authorizations - API
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New Market Authorizations – API
With a proven expertise in handling all types of API (chemical/ fermentation/ sterile/ biologicals), Excipient and Pre-mix master-file submissions to global health authorities, AARIYA is one of preferred Regulatory partner across the globe in regulatory writing, review and compilation of:
- Drug Master Files (DMFs)
- Active Substance Master Files (ASMFs)
- Certificates of Suitability (CEPs)