Overview

As part of the international multicentre development programs, global pharmaceutical companies are turning towards Japan for conducting clinical trials. That shows a great sign for drug development in Japan. To be a part of the Japan’s pharmaceutical market, however, foreign drug developers need to balance great advantages of country’s growing market opportunities with that of the stringent registration and Regulatory pathways laid out by the Pharmaceuticals and Medical Devices Agency (PMDA), country’s Health Authority.

With an exceptional market knowledge and regional Regulatory affairs, Freyr assists foreign manufacturers to streamline their drug approval process cost-effectively and in a timely manner. To expedite your drug’s Japan market-entry, Freyr offers comprehensive Regulatory services right from Regulatory intelligence to dossier preparation and submission to drug approvals. 

Freyr Expertise

Quality

  • Quality Management System (QMS)
  • Good Quality Practice (GQP)
  • QMS Application to PMDA
  • Preparation for PMDA Inspection
  • Local Product Release
  • SOP Writing
  • Quality Manual Writing
  • FMA Application
  • Due Diligence Audits

Clinical

  • CRO Oversight and Management
  • Product Development
  • In-country Caretaker (ICC) for Clinical Trials in Japan
  • Clinical Trial Notification (CTN)

Safety

  • Receipt, Review and Coding of Adverse Events
  • Safety Reports to PMDA