IND / IMPD Services
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies offers the skills and capability to prepare and review documents for clinical trial application (IND/IMPD).
This includes:
- Manufacture and support for Phase I, Phase II and Phase III studies
- IND / IMPD quality sections related to drug substance and drug product: manufacturing, control, stability, description of clinical supplies, including placebo and comparators
- Responses to Questions during assessment procedure.
Choose Eurofins CDMO network of companies to help you:
- Build and convey product and process knowledge
- Develop and document a phase-appropriate supply chain
- Determine and document phase-appropriate analytical controls
- Establish and present supportable, fit-for-purpose regulatory concepts
- Document key product chemical and physicochemical quality control points
- Set the stage for subsequent-development
