Tackling CMC Authoring Challenges

Authoring Chemistry, Manufacturing and Controls (CMC) dossiers is a complex process. Information is collected from the early development to the approval of the Marketing Authorization and beyond once the product is commercialized.

Before a medicinal product can reach the wider population of patients, clinical studies take place. This will ensure the safety and efficacy of a product for its intended use. A product used in humans is subject to high scrutiny from the Health Authorities and clinical studies are closely supervised. Biopharmaceutical companies need to provide precise information on the quality of the product. For example: how and where is the drug made, what kind of materials are used and how are they tested, how can the methods used to test the raw materials assure product consistency and quality, how long can the product be used, how have the specific quality attributes been identified and how they are controlled and monitored.

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