IND / IMPD Services
Eurofins CDMO (Contract Development & Manufacturing Organization) offers the skills and capability to prepare and review documents for clinical trial application (IND/IMPD).
- 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 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