Pharmacovigilance System

  • Establishment and maintenance of your PV system including qualified person for pharmacovigilance (QPPV and deputy QPPV)
  • Preparation and maintenance of SOPs and quality management systems

Pharmacovigilance Audits

  • External audits of your PV system
  • Pre-inspection audits to make sure your system is fully compliant with the latest regulatory requirements
  • Assistance during the inspection processes, development of CA/PA, and dealing with critical findings

PV Training

  • Tailored-made in-house training for your PV specialists, associates, or managers
  • Coaching of your QPPVs and top management in drug safety issues
  • Training of medical and sales representatives

Pharmacovigilance System Master File (PSMF)

  • Development of a new PSMF, or peer review of your existing system
  • Maintenance of the PSMF
  • Assistance with responses to regulatory enquiries