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Regulatory Approvals
Our regulatory approvals team is in charge of providing all technical documentation adhering to MOH guidelines with respect to our APIs and Formulations.
- Classification of preliminary documentation and regulatory requirements for submissions.
- Compilation of Dossier and Drug Master File as per EU GMP, USFDA, PIC/S, GCCand other regulatory authorities.
- Complying to ICH guidelines and Pharmacopoeiaconcerningthe Purity profile, MOA validation, Stability studies-zone, Toxicology studies etc.
- Collaboration for out-licensing Bioequivalence / Bioavailabilityand related diagnostic studies.
- Comprehensive regulatory data management and prompton-callsupport.
- Call for Market Authorization Application.