Chemistry, Manufacturing and Controls (CMC)

CMC is integral to the development of medicinal products ensuring that they are of consistently high quality and safe to use.

Artemida Pharma offers a fully integrated CMC service headed by Peter Tiffin. Our expertise covers drug substance and drug product development and manufacture through to regulatory approval. We have international experience and have worked with a range of global Contract Manufacturing Organisations (CMOs).

The team provides expert advice and comprehensive project management services to clients, including:

  • Development strategies that are phase appropriate to help advance potential drugs through clinical trials to approval
  • Advice on CMC due diligence packages to enable timely decision making whilst minimising risk
  • Support the search and selection of suppliers
  • Liaison and management of manufacturing activites with global CMOs
  • Auditing for compliance with Good Manufacturing Practices
  • Preparation and maintenance of CMC sections of regulatory documents from early phase trials (INDs and IMPDs) to New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs).
  • Ad-hoc CMC regulatory support