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