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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