Our CMC regulatory services are designed to help you navigate the complex CMC regulatory landscape and comply with the continuously improving regulatory framework.
CMC Dossier Compilation
- IND and IMPD compilation
- NDA CTD compilation
Scientific Advice Meeting Assistance
- Briefing package compilation
- Type B, Type C and Type D meeting assistance based on development stage
- Creating a list of questions based on project status and development roadmap
- Representing sponsors as CMC and quality resource/expert
- Post scientific advice meeting assistance to fulfill regulatory commitments
Other Regulatory Services
- Scientific assessments for manufacturing and analytical changes
- Scale-up and site transfer documentation
- Process optimisation justification
- Analytical method changes