Our Services

Pharmacovigilance

OWLPHARMA features a complete pharmacovigilance service for medicinal products in compliance with the responsibilities of the MAH.

We offer a full integrated solution that comprises an adequate and effective pharmacovigilance system, performing all required pharmacovigilance activities, or a tailored solution if only specific activities are required.

Our Services include:
  • EU QPPV and Local QPPV
  • Local and worldwide literature search
  • PSMF and SOP elaboration
  • Risk management plans
  • Periodic safety update reports
  • Signal detection and Benefit-Risk evaluation
  • Medical assessment
  • Safety variations
  • ICSR reporting
  • System monitoring
  • Training and audits