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

Multidisciplinary global team

Our team is composed of world-class experts with 30+ years of Japan experience.

Integrated robust strategy

We cover Regulatory Affairs, Drug Development, Licensing and Commercial Strategy.

Flexible and client focused

We are agile with strong focus on our clients. We cater our services to meet their unique needs.

Excellent communication

We are a perfectly bilingual team with a culturally-sensitive communication style.