CMC (Chemistry, Manufacturing and Control) is an integral part of drug development, license applications and the on-going marketing of a medicinal product. As drug development moves from concept to commercialisation, the breadth and depth of CMC documentation required in submissions increases in parallel.
Across the team TRAC has over 30 years recent CMC experience spanning global markets and offers a broad range of services to support CMC activities at every stage of the product lifecycle from preparing a Module 3 dossier to completing a CMC Compliance Gap Analysis/Due Diligence and delivery of the remediation plans.
Contact us today to find out more about our CMC services.
