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Antovic SRL — Inteligencia regulatoria
Team of professionals reviewing regulatory solutions in a working meeting

A route for every challenge

Health surveillance

Safety decisions require timely, reliable, quality information. Our broad pharmacovigilance experience makes us the ideal strategic ally to strengthen your processes, optimize local operations and support compliance with current health requirements.

Our services

  • We structure and design pharmacovigilance units or equivalents at hospital, industrial, importer, distributor, community pharmacy and compounding pharmacy level, under a strict quality management system.
  • Comprehensive case management through processing and validation of suspected adverse drug reactions, therapeutic failure and events supposedly attributable to vaccination and immunization.
  • Systematic review of pharmacological scientific literature.
  • Preparation and submission of Periodic Safety Update Reports (PSUR).
  • Preparation and submission of Risk Management Plans.
  • Development of Technovigilance programs.
  • Development of Cosmetovigilance programs.
  • Audit of Good Pharmacovigilance Practice compliance.

Let's talk about your process

Tell us the context and we will come back with a concrete regulatory route, with defined timings and owners.

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