Medical Devices Vigilance

INTEXO caters for the needs of Companies which want to outsource their Italian and International vigilance activities; we put a professional team at the Customer’s disposal, whose mutually complementary areas of expertise cover all the safety management of pharmaceutical products (for human and veterinary use), of medical devices, cosmetics and other products for human use.

intexo brochure farmacovigilanza anteprima estesa

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Pharmacovigilance services:

  • Full Management of Corporate Pharmacovigilance Services
  • Partial Management of Pharmacovigilance activities
  • On Demand Management (vertical or horizontal part time)
  • Literature research
  • Support for the reengineering of Pharmacovigilance System
  • Training to Reps
  • Preparation to regulatory inspections (mock inspection), Due diligence and Audit to Third Parties, Audit to Service Provider and Affiliates
  • Leasing and management of validated database
  • Preparation and review of Procedural Systems
  • PSMF, PSUR and RMP preparation
  • Management of Signal Detection
  • Eudravigilance ed XEVMPD
  • Support in safety litigation

For further information, contact: