Pharmacovigilance Support & Post-marketing Services

  • External PV function (incl. database maintenance)
  • Qualified person (QP) for PV
  • Services about: variations, renewals, Switch RX to OTC
  • Development & implementation of SOPs
  • Literature Screening
  • AE assessments and reporting
  • Periodic Reporting (PSURs)
  • PV in clinical trials & PSMF
  • Quality assurance support for GLP & GLP; ISO 9000 certificate preparation
  • Establishing a inhouse PV System

We also want to inform you about the latest news in pharmacovigilance. They can be seen in the online journal “Periodic Safety Report” from “EU Vigilance”. EU Vigilance is a strong cooperation partner of P.SS.T for our PV activities. EU Vigilance has a huge network for QPPVs.logo01

P.SS.T Service Concept