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.