Provision of IMP related documents:

  • preparation and review of IMP sections in trial protocols
  • preparation of a full or abbreviated Investigational Medicinal Product Dossier (IMPD)
  • IMP guidance section of Investigator’s Brochure (IB)
  • manufacturing documentation – e.g., Certificate of Compliance,
  • generation of randomization list / unblinding list
  • Code Breaking Cards (CBC) / Randomization Envelopes
  • IMP batch release by QP in accordance with Directive 2001/20/EC
  • QP statements related to imported IMP are prepared based on audits of the manufacturer’s production site(s)

IMP documentation respects the interface between Good Manufacturing.

This site uses cookies to improve the browsing experience of users and to gather information on the use of the site.
Can know the details through our Privacy Policy. Continuing navigation we accept the use of cookies; otherwise you can leave the site.