PHARMACOVIGILANCE SERVICES

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