• Reflection on product development plan according to pharmaceutical requirements for Europe and US registration (on various pharmaceutical forms such as solution/suspension for injection, oral solution, tablet, hard capsule, oral powder, ointment …)
  • Validation of regulatory strategy with Europe and US Authorities (for innovative product application, generic application, hybrid application, fixed combination application)
  • Writing/ Review of Pharmaceutical Technical Documentation of the registration file for Europe (CTD Module 3 format for Human or NTA Part 2 format for Veterinary)
  • Writing of Pharmaceutical Expert Report for Europe (Part 1C – Critical Assessment and written summaries)
  • Writing/Review of Variation Documentation for Europe (Type IA & IB notification, Type II variation)
  • Writing/Review of Chemistry, Manufacturing and Control (CMC) section of the registration file for US (CTD Module 3 format & Module 2 Quality Overall Summary)
  • Quality Control of CMC (QC Check)
  • Writing/Review of Supplemental Documentation for US (Prior approval supplement, Changes being effected in 30 days (CB30), annual report)