voisin consulting

CMC/Quality

Voisin Consulting Life Sciences proposes complementary CMC and Regulatory services and provides expertise to fulfill the various Quality sections of regulatory filings such as Module 3 of the CTD following EU and US requirements.

We believe that effective product development requires strong technical background and robust regulatory expertise. Our CMC group was therefore built with team members having significant pharma/biotech industry experience in product development, technology transfer, analytical development, Quality Control and CMC regulatory affairs. This makes us well prepared to interface efficiently with the technical and regulatory teams and help coordinate CMC activities in line with the development phases of our client’s programs.

Technical support

  • Management of complete technology transfer projects
  • Coordination of manufacturing and method transfer
  • Identification of Contract Manufacturing Organizations and analytical laboratories
  • Support with writing Qualification and Validation protocols and reports
  • Assessment of Quality Systems and compliance with cGMP.

We become part of our client’s team and interface with all parties involved in the program to ensure that appropriate information is generated and effectively utilized.

Regulatory support

  • Pharmaceutical sections of IMPDs for Clinical Trial Applications
  • Module 3 and 2.3 of MAA, BLA or NDA submissions
  • Briefing packages for Scientific Advice or Protocol Assistance
  • Participation in Agency meetings at all stages of development
  • Design of comparability strategies
  • Viral Safety assessment for biological products.

Overall, we approach CMC development in a pragmatic manner adapted to each product’s complexity, taking into account the evolving quality and regulatory paradigms and keeping in mind similarities and differences between regions.

bsi

Cambridge • Lausanne • Paris/Rennes • Bangalore • Singapore •  London

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