Chemistry and Manufacturing Controls (CMC)

Chemistry and Manufacturing Control (CMC) is the FDA term used globally to describe the data for the manufacture and testing of a medicinal product. In Europe, the ICH term, Module 3 Quality, is more commonly used. The two terms are interchangeable.

The CMC aspects of the regulatory submission will cover

  • Characterisation of the active substance
  • Composition of the dosage form
  • Raw materials used to manufacture the active substance and finished dosage form
  • Description of the product and process development
  • Description of the manufacturing processes
  • Release and stability testing data for both the active substance and the dosage form
  • Analytical methods and specifications used for testing and release of raw materials
  • In-process controls
  • Container and closure systems

CMC is an integral part of drug development, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. As drug development of the dosage form moves from concept to commercialisation, the breadth and depth of CMC documentation required in submissions increases in parallel. All regulatory submissions require CMC data e.g.:-

  • IND
  • CTA
  • MAA
  • Variations
  • NDA
  • Annual reports

consult2deliver can help you prepare, assemble and review the required documentation and reports for CMC/Module 3 data. Our professional approach ensures that our clients medicinal products are consistently effective, safe and of a high quality for consumers. Our key capabilities are networking and relationship building, as creation of the CMC data requires collaboration with multiple technical groups or with external contractors e.g. if a contract manufacturing organisation (CMO) is used whilst mindful of the commercial environment.

consult2deliver are able to advise on queries from UK, EU and US regulatory authorities. We will collaborate with our clients to form a strategy to resolve scientific technical or regulatory issues.

Preparation of a Module 3 dossier may be required following

  • CMC compliance gap analysis,
  • due diligence analysis
  • need for scientific advice meeting