Chemistry, Manufacturing and Controls (CMC)

Our CMC services are primarily for drug substances of synthetic or semi-synthetic origin and include the Chemistry and Manufacturing (CM) part only. Additionally CMC is required for applications for new dosage forms, new strengths, and other changes to authorized products which require the filing of a supplementary application/submission. CMC services for Biological/ Biotechnological drugs are provided on a case to case basis.

CM services are provided for new active pharmaceutical ingredients (APIs), existing APIs and their corresponding drug products. Our clients may choose to hire us for any one or wholesome of the following list of services.

Drug Substance
- Master Files (MFs)
- Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs)
General Information
- Nomenclature
- Structure
- General Properties
Manufacture
- Description of Manufacturing Process and Process Controls
- Control of Materials
- Controls of Critical Steps and Intermediates
- Process Validation and/or Evaluation
- Manufacturing Process Development
Characterisation
- Elucidation of Structure and other Characteristics
- Impurities
Control of the Drug Substance
- Specification
- Analytical Procedures
- Validation of Analytical Procedures
- Batch Analyses
- Justification of Specification
Reference Standards or Materials
Container Closure System
Stability
- Stability Summary and Conclusions
- Post-approval Stability Protocol and Stability Commitment
- Stability Data

Drug Product

(Section P)

Drug Product
Description and Composition of the Drug Product
Pharmaceutical Development
- Components of the Drug Product
- Drug Product
- Manufacturing Process Development
- Container Closure System
- Microbiological Attributes
- Compatibility
Manufacture
- Manufacturer(s)
- Batch Formula
- Description of Manufacturing Process and Process Controls
- Controls of Critical Steps and Intermediates
- Process Validation and/or Evaluation
Control of Excipients
- Specifications
- Analytical Procedures
- Validation of Analytical Procedures
- Justification of Specifications
- Excipients of Human or Animal Origin
- Novel Excipients
Control of Drug Product
- Specification(s)
- Analytical Procedures
- Validation of Analytical Procedures
- Batch Analyses
- Characterisation of Impurities
- Justification of Specification(s)
Reference Standards or Materials
Container Closure System
Stability
- Stability Summary and Conclusions
- Post-approval Stability Protocol and Stability Commitment
- Stability Data