CMC – Chemistry, Manufacturing and Control

CMC documentation includes all documents related to all aspects of the chemistry, manufacturing and control of drug substances and drug product.

LINK offers assistance and may take care of all steps in the preparation and assembly of CMC documentation for all kinds of regulatory submissions, including applications for clinical trials, new marketing authorisations and maintenance of marketing authorisations, i.e.:

• Clinical Trial Applications: Preparation of the CMC part of the Investigational Medicinal Product Dossier (IMPD).
• Marketing Authorisation Applications (MAA): Preparation and assembly of the CMC part (Module 3) of the dossier and preparation of the quality overall summary (QOS) for Module 2.
• Maintenance of Marketing Authorisations (MA): CMC variation applications.