Regulatory Submission

We'll prepare and update all non-clinical development documents required for approval and registration of your drug. Our Regulatory Submission Service includes:

  • creating and updating investigator information for clinical trials (Investigator's Brochure, IB)
  • authoring and reviewing non-clinical sections of Investigational Medicinal Product Dossiers (IMPDs) and Investigational New Drug Applications (INDs)
  • creating and reviewing modules 2.4, 2.6 and 4 of the Common Technical Document (CTD)
  • non-clinical support of European (Centralized Procedure (CP), Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP)), US (New Drug Application (NDA), Biologics Licence Application (BLA)) and other non-European approval procedures.
  • preparing non-clinical data for SEND (Standard for Exchange of Non-clinical Data)
  • reviewing and creating tabulated summaries
  • auditing and adaptating research reports for use in regulatory documents