Regulatory Services – Japan
With an office in Tokyo, Japan, our expert team is locally positioned to develop strategic regulatory plans, facilitate Agency meetings and interactions, work with KOL liaisons, and develop bridging studies.


Regulatory Affairs and Compliance

PMDA consultations (From Pre-Phase 1 to pre-NDA, RS consultation etc.)

Support CRO activities throughout Japan



Business Development

KOL Liaison Work

Bridging Studies



Drug Master File (MF), Japan Accepted Name (JAN), Foreign Manufacturer Accreditation (FMA)

Translation Work

Orphan drug designations, Sakigake designation



Regulatory Services – Japan