All regulatory authorities require information relating to the manufacture and testing of a product when applying for approval of a new drug. For the FDA, this is captured in the Chemistry, Manufacturing and Controls guidelines. CMC information is required when submitting IND, NDAs, ANDAs and Annual reports. The required content varies dependent on the type of substance or product.
PSC can help you prepare, assemble, and review the required documentation and reports. We can also handle CMC-related queries from US and international health authorities, and coordinate and participate in meetings with relevant authorities to resolve scientific technical or regulatory issues resulting from a review of submission or compliance action.
If you would like more information, get in contact with us directly here.