PHARMACOVIGILANCE

Entrust your pharmacovigilance concerns in the experienced hands of our Team. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire pharmacovigilance processes – our knowledgeable consultants will be there for you.

  • Services of EU QPPV, Local QPPV
  • Pharmacovilgilance System Set up and Review services
  • ICSR management
  • On-going monitoring and signal management
  • Literature surveillance services
  • Risk management
  • Reporting
    – Product Safety Update Reports (PSURs)
    – Periodic Benefit-Risk Evaluation Reports (PBRERs)
    – Development Safety Update Reports (DSURs)
    – Periodic Adverse Drug Experience Reports (PADERs)
    – Risk Management Reports (RMPs)
  • Safety Data Exchange Agreements
  • Pharmacovigilance Quality System, audits and inspections
    – Pharmacovigilance System Master File (PSMF)
    – Standard Operating Procedures (SOPs)
    – Internal and third party audits, mock-up inspections, CAPA writing
  • Training