Pharmaco Vigilance

We cover a wide range of areas regarding safety and pharmacovigilance in Japan:

  • Strategic Advice and Operational Support on any aspect related to safety and pharmacovigilance in Japan
  • Preparation and Review of SOPs for GVP (Good Vigilance Practice) and GPSP (Good Post-marketing Study Practice)
  • Assessment and Review of safety documents (Module 1, Module 2, RMP, etc.) for submissions to PMDA
  • Consultation and Interactions with PMDA regarding safety matters
  • Gap Analysis of global documents to meet Japan-specific requirements
  • Strategy and Management of PMS, EPPV, Periodic Safety Reports