Evaluation of dossiers

  • Technical & regulatory audit/ evaluation of pharmaceutical dossiers (Module 3 or Part 2), ASMF, CEP
  • Evaluation of technical data (chemical and pharmaceutical)
  • Regulatory strategy proposal

Writing of dossiers

  • Writing in French and/or English, translation of any technical documents.
  • Quality part (human and veterinary medicines)
    • IMPD, MA, variations, updating/ renewal
    • ASMF (Europe), CEP
    • Preparation and signature of the Quality Overall Summary by an internal or external Expert
    • Answers to questions from Authorities
    • Reformatting to the CTD format
  • Veterinary medicines : Part 3 – pharmacotoxicology - and Part 4 – efficacy
    • Documentation: publications, specific studies
    • Synthesis of documentation, tabular summaries
    • Preparation and signature of the Expert report

Consulting and expertise

  • Regulatory intelligence
  • Consulting for pharmaceutical development
  • Strategy for variations
  • Follow-up with Agencies and external Experts
  • Troubleshooting : to support investigation of a quality problem of a marketed product