Medical devices

SPECIFIC CONSULTATIONS AND PRODUCTS

  • Preliminary consultancy, project definition and management.
  • Feasibility study and data gaps (ingredients and products).
  • Consultancy on new EU Regulation.
  • Strategic/regulatory consultancy.
  • MD class definition.
  • Clinical and biological evaluations.
  • Study Monitoring (toxicological, clinical, efficacy).
  • Human Health Risk Assessment.
  • Review/preparation of technical documentation files (dossiers).
  • “In silico” prediction for toxicology, genotoxicity and metabolism.
  • Liason with Regulatory Bodies (EU/USA level).
  • Legal advice.