Medicinal Products

  • Local QP/contact persons for PV in the EU member states
  • Clinical Trials and post-marketing Vigilance
  • Annual safety reports (ASRs) (for NCA and ECs)
  • Case processing for ISCRs/SAEs (Including collection, collation, coding analysis, reporting and electronic archiving of the ADRs)
  • Consultancy strategy and advice
  • Periodic safety update reports (PSURs)
  • Risk Management Plans
  • Safety Data Exchange Arrangements (SDEAs)
  • Preparation for PV inspections, post-inspection support
  • Company Core Data Sheets (CCDS) and Core Safety Information (CCSI)
  • Weekly and bespoke literature searching
  • Review of safety systems, Standard Operation Procedures (SOP) preparation