Chemical Manufacture and Control (CMC)

This comprises module 3 of the Common Technical Dossier (CTD) covering the quality aspects of the Drug Substance (DS) and Medicinal Product (MP). In this aspect the following services are provided:

  • Reviewing and assessment of Module 3 of the dossier ensuring compliance with the requirements of the relevant Directives and guidelines.
  • Revision of different dosage forms including sterile and modified release preparations among many others. Following are examples of specialised topics carried out and services provided:
    • Formulation development and dissolution performance linked to bioavailability and conditions for biowaiver.
    • Pharmaceutical analysis methods development & validation with special interest in HPLC techniques and analysis.
    • Protocols and reports for manufacturing process validation
    • Specification monograph design, testing parameters and limits
    • Stability studies and kinetics ensuring compliance with the requirements and recommendations of guidelines.

Reference: Notice to Applicants, Volume 2B, Presentation and format of the dossier (CTD)