A US corporation, Global Regulatory Partners, establishes its subsidiary in Tokyo to help foreign pharmaceutical and medical device companies register their products in Japan
Jul 20, 2017
Global Regulatory Partners LLC is a US firm that provides a full spectrum of consultation on regulatory affairs, clinical trials, quality and safety to medical device and pharmaceutical companies worldwide.
Global Regulatory Partners LLC was founded in 2010 in the state of Massachusetts (Boston area) in the United State of America. In 2016, the company extended its footprint and operations to Asia by opening subsidiaries in China and Japan in August 2016 and in October 2016 respectively. This June, the Japanese subsidiary, Global Regulatory Partners GK, obtained the first-class marketing authorization holders (MAH) license from the Tokyo Metropolitan Government for medical devices and in vitro diagnostic products and can therefore act as the MAH of foreign life science companies in Japan.
The goal of Global Regulatory Partners GK is to help foreign medical device and pharmaceutical companies access the Japanese market by registering their products with the Pharmaceuticals and Medical Devices Agency (PMDA), managing their clinical trials and handling their compliance activities. Additionally, the company is aiming to help Japanese life science companies access the US market as well by registering their medical devices and drugs with the US Food and Drug Administration (FDA).
For the establishment of their base in Japan, JETRO Invest Japan Business Support Center (IBSC) provided services such as consultation on labor affairs, market information provided by industry advisors and referral to service providers, such as administrative scriveners, accounting firms and human resource agencies.