With a comprehensive Regulatory framework, Japan stands a competitive market for foreign medicinal and medical devices manufacturers while investing in the region. Not only the stringent regulations inclusive of language barriers, but also the expensive Regulatory procedural challenges demand a special attention from manufacturers, who are willing to enter the region. To get the market access, manufacturers must comply with Japan’s Pharmaceutical and Medical Device Act (PMD Act), which is regulated by the Pharmaceutical and Medical Devices Agency (PMDA).

Leveraging our cutting-edge knowledge on the Japan’s Regulatory Affairs, Freyr, as a specialized Regulatory partner, can assist foreign manufacturers to streamline their device approval process cost-effectively and in a timely manner. Freyr’s Regulatory services in Japan span across:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Marketing Authorization Applications, Post Marketing Maintenance
  • Preparation of application dossier
  • Food label translation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines