PV Pharmacovigilance

We provide our clients with high quality strategic and operational support in pharmacovigilance.

We offer:

Analysis and interpretation of safety data

  • Signal detection, safety issue work-ups, crisis management, ‘Dear Health Care Professional letters’
  • Preparation of PSURs/PBRERs, RMPs, PSMFs, safety summaries for regulatory submissions or IND annual reports
  • Writing and/or review of SAE narratives for CSRs or independent Data Safety Monitoring Boards (DSMBs)

Strategic advice

  • Interactions with PRAC including public hearings
  • Need for and conduct of independent DSMBs
  • Potential use of EU PV data for US applications

System advice

  • Advice on quality management systems, audits, SOPs, training