Patient safety is paramount at every stage of your product lifecycle. We provide comprehensive and flexible solutions for the active management of drug safety, pharmacovigilance and risk management during the complete lifecycle of a medicinal product. Our pharmacovigilance team consists of experts with broad therapeutic expertise that work according to the latest regulatory requirements.

  • EU QPPV / LPPV Services

  • Risk Management Plan

  • PSURs (periodic safety update reports)

  • DSURs (Development Safety Update Report)

  • PhV Audit support

  • KPI report preparation

  • Reports Management Assessment

  • Educational materials

  • Comunication of DDLs

Data collection services for Pharmacovigilance activities:

  • Local medical literature screening (Romania and Moldova)

  • Local medical scientific events monitoring

  • 24/7 call centre system for AE reporting, quality complaints, providing medical information and medicines’ availability

  • Social media and medical forums monitoring for AE reporting