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
