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)