- 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.
- 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.