Regulatory Affairs- pharmaceuticals and Medicinal Cannabis

The areas in which we can make a difference include:

  • Preparation of the components of the Common Technical Document (CTD) – Chemistry, Manufacturing and Controls (CMC) and Non clinical documents: Non Clinical Overviews, and Summaries (Modules 2.4, 2.6) & Non-clinical Assessment Report (module 4)
  • Prepare the ecotoxicological dossier (module 1.6)
  • Preparation of Marketing Applications (New, Variations, Renewals)
  • Submission to the Health Authorities (National, CP, MRP & DCP)
  • Compilation of documentation for Marketing Authorisation
  • Preparation and submission of applications for authorisation to manufacture cannabis intermediate products
  • Preparation and submission of applications concerning import of cannabis primary products

Further information regarding services, expertise and how our experience can support your business; please contact us at +4526709648, Email: info@toxregulatoryaffairs.com