We conduct detailed compliance reviews of the Chemistry, Manufacturing, and Controls (CMC) section of your regulatory filings (NDA/BLA/MAA). Services include gap analysis of Module 3 filings, stability data review, batch analysis, and specifications justification.

We employ protocols such as PPQ, CPV plans, and scale-up validation to establish evidence that your manufacturing process consistently produces a product meeting its intended quality attributes.

We ensure your laboratory testing methods are accurate, precise, and compliant with ICH guidelines. We utilize method transfer protocols, verification of compendial methods, and validation of stability-indicating assays.

We provide quality assurance review and approvals for supply chain services to support clinical release. We validate the movement and storage of products to ensure efficacy remains intact from the factory to the patient.