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