The Artemida Pharma CMC team provides expert strategic advice and comprehensive project management services to clients including:
- Phase appropriate development strategies to advance molecules through preclinical and clinical development
- Our expertise covers drug substance process development and manufacture, pre-formulation, formulation and drug product manufacturing
- Advice on CMC due diligence packages enabling timely risk based decisions to be made
- Supplier search and selection with a range of global suppliers
- Auditing for compliance with Good Manufacturing Practices (GMPs)
- Preparation and maintenance of CMC sections of regulatory documents from early phase submissions to New Drug and Marketing Authorisation Applications (NDAs and MAAs)