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SAFETY & PHARMACOVIGILANCE

Pharmacovigilance partner with comprehensive safety and vigilance solutions

We specialise in comprehensive global drug safety solutions, providing partial or full outsourcing of pharmacovigilance responsibilities of the pharmaceutical and biotech companies. Our experienced team with deep domain knowledge ensures optimal compliance with the pharmacovigilance regulations.

Services We Offer

  • Strategic Pharmacovigilance Services
  • PSMF Management
  • PV Intelligence
  • MICC Support Call Centre
  • GVP Audits and Support
  • Safety Database implementation
  • Safety Data Exchange Agreements Management
  • Risk Minimisation measures and effectiveness checks
  • Aggregate Reports – DSURs, PSURs, PADERs, PBRERs
  • Signal Detection
  • Risk Evaluation and Mitigation Strategy & Risk management plan
  • Implementation of outcomes of safety referrals & procedures concerning PSURs, PASS, signal assessments & PAMs
  • Pharmacoepidemiology
  • Global labelling (CCDS updates)
  • EU QPPV & QPPV services
  • Global & local PV services. PV Quality systems
  • Pharmacovigilance system set-up
  • Periodic Adverse Drug Experience Report