Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs Services

Bridging Regulations and Science

Having worked for larger (bio)pharmaceutical industry companies as well as regulatory agencies, ProPharma Group’s consultants are well-suited to help you determine an optimal Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for your product. Our CMC services ensure your documentation is of consistently high quality as well as being technically valid, meeting the requirements of various Agencies.

Our consultants support the Regulatory Affairs (RA) writing process which feeds into all possible submissions, aligning with the Module 3 format for both clinical trial applications (e.g. IMPD & IND) and applications for marketing authorization (e.g. MAA, BLA, NDA). We are accustomed to working in close collaboration with your internal team for development, manufacturing, QA, QC, and RA. In addition, we are also available to provide several consultants who previously worked at FDA, EMA or local EU Health Authorities who will guide you through the processes for your project, right when you need it.