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Pharma – Cosmetic – Food Supplements

The registration process requires expertise in terms of quality and evaluation of the efficiency and the risk related to the product. Regulatory Experts write client’s files, ready for submission to supervisory authorities and adapted to client’s particular requirements as well as to the concerned type of product: pharmaceuticals, medical device, cosmetic, dietary supplement.

Pharmaceuticals

  • Files drafting (CTD modules 1, 2, 3, 4, 5)
  • Expert report (2.3/2.4/2.5)
  • Risk management plan
  • IMPD and investigator brochure drafting
  • Instruction guide legibility testing
  • Editorial changes
  • Laboratory representation for health authorities

Medical devices

  • CE tagging dossier drafting (class I to III)
  • Clinical safety evaluation
  • Risk management (ISO 14971)
  • Analysis of the suitability for use (ISO 62366)
  • Setting up and management of QMS for clients (process, documentation, deviation claims, preventative and corrective action)
  • Manufacturer representation for notified organisms

Cosmetics

  • Product information dossier drafting (regulation 1223/2009/CE)
  • Notification to the European Commission
  • Report on cosmetic product safety (Annex I of 1223/2009/CE)
  • Setting up GMP (ISO 22716)

Dietary supplements

  • Notification dossier drafting (France and worldwide)
  • Investigator brochure (for clinical trial)