Freyr provides Japan medical device registration and approval support for device manufacturers that includes registration, classification, MAH and D-MAH agent services for product compliance as per PMDA regulations. Though the market looks promising, the major barrier in obtaining medical device approval in Japan market is the stringent Pharmaceuticals and Medical Devices Agency (PMDA) regulations that companies must abide by.
Freyr provides Japan Drug Registration and Approval support for pharmaceutical manufacturers that includes product classification, registration and approval for regulatory compliance as per PMDA regulations. As of 2024, Japan’s pharmaceutical market has continued to grow steadily, with sales reaching $67.5 billion, further solidifying its position as the third-largest pharmaceutical market globally, following the United States and China.
“Contact Freyr for Japanese End-to-End regulatory services to comply with PMDA & MHLW regulatory Requirements. We are strategically located across regions like the Americas, Europe, Asia-pacific, and Africa and Middle East.
Below listed are a few of our global delivery centers, customer support centers, and offices.”
Commenced operations in the United States (US) with a small set-up and a 5-member core team. Launched Freyr EVMPD. Roped in our first customer, a Germany-based multinational pharmaceutical company. Freyr is a leading Regulatory solutions provider offering comprehensive services to life sciences firms across the regulatory spectrum. With a robust presence spanning over 120 countries, we facilitate successful market entry in Japan for Pharmaceutical & Lifesciences companies.
Top Message “Market has always been the guru for us. It is guiding us and shaping us at every step of our growth. At Freyr Life Sciences K.K., we cultivate a highly dynamic and exciting work environment. Our clients represent some of the world’s most innovative companies in the life sciences sector, whose innovations contribute to the health promotion, longevity, and quality of life enhancement for millions of people worldwide.
Freyr provides End-to-End Regulatory Services in Japan to the pharmaceuticals, Medical Device, Food Supplements, and Cosmetic Companies to comply with PMDA Regulations. Freyr is a leading Regulatory solutions provider offering comprehensive services to life sciences firms across the regulatory spectrum. With a robust presence spanning over 120 countries, we facilitate successful market entry in Japan for Pharmaceutical & Lifesciences companies.
