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IND / IMPD Services

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Eurofins CDMO (Contract Development & Manufacturing Organization) 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 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