Effective pharmacovigilance is crucial for ensuring ongoing evaluation and oversight of the safety profile  

Pharmacovigilance (PV) is essential for safeguarding patients’ health, meeting stringent regulatory requirements, and ensuring the overall safety of pharmaceutical products. Our team of highly qualified PV specialists will guide you through the entire process, from proactive risk consideration to post-market PV systems.

  • Full Pharmacovigilance Service Support, including QPPV and Deputy QPPV
  • Pharmacovigilance System Setup and PSMF Development/Maintenance
  • Ongoing Global and Local Literature Monitoring
  • EudraVigilance Support, including Mandatory Medicinal Product Data Reporting to XEVMPD
  • Continuous Safety Surveillance, Signal Detection Validation, Evaluation and Further Processing
  • Risk Management, including RMP Development and Risk Minimization Measures Handling
  • Preparation and Submission of PSURs
  • Medical Information
  • Audits and Inspections Handling
  • Veterinary Post-Market Vigilance Expertise

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