Stratégie Santé - Regulatory Consultant for Drug Registration


Writing

> Chemical and Pharmaceutical Documentation

  • EDMF / ASMF
  • Certification of Suitability to European Pharmacopoeia
  • Quality Dossier (Module 3): chemical and herbal medicinal products
  • Quality Overall Summary (Module 2.3.)
  • Minor and Major Variations

> Pre-Clinical Documentation

  • Bibliographic Synthesis
  • Non Clinical-Overview (Module 2.4.)
  • Non Clinical-Summary (Module 2.6.)

> Clinical Documentation

  • Clinical Study Reports
  • Clinical Overview (Module 2.5.)
  • Clinical Summary (Module 2.7.)
  • Scientific Publication, Poster

> Transparency file

  • "Note d'Intérêt Thérapeutique"

> Other

  • Cosmetology : quality dossier and safety assessment
  • Homeopathy

9, rue Saint Florentin - 75008 PARIS - FRANCE - Tel: 33.1.42.86.86.00 - Fax: 33.1.42.86.84.71