Neuroceuticals Forms Business Alliance with Regulatory Affairs Support Company NeuroCeuticals Forms Business Alliance with Expert Partners Japan, a Regulatory Affairs Support Company

2023.10.18 09:30

株式会社ニューロシューティカルズ

Neuroceuticals, Inc. (Head office: Bunkyo-ku, Tokyo; Representative Director: Shinya Miike; hereinafter "NCI"), a medical device development venture company, has entered into a business alliance agreement with Exponent Partner Japan Inc. (Head Office: Chuo-ku, Tokyo; President: Hideki Fujitsuka; hereinafter "EXP"), a company specializing in medical device regulatory affairs.

NCI Regulatory Affairs Support Business Alliance

Background of the Business Alliance

NCI is a company that promotes medical device development and also functions as an incubator to foster medical device venture companies by making venture investments from its own and affiliated funds. As part of these activities, NCI has decided to collaborate with EXP, a regulatory affairs support company specializing in medical devices, to provide full support in complying with regulatory requirements, which are said to be the most difficult hurdle in the medical device commercialization process from a practical standpoint. In addition, both companies plan to promote business expansion through mutual client referrals.

Outline of the Business Alliance

EXP possesses regulatory support services cultivated over many years, and will provide full support for development projects commissioned by NCI and for regulatory affairs of venture companies in which NCI and others invest. On the other hand, NCI will contribute to the development of the medical device industry in Japan by providing support for venture companies from fund procurement to development and obtaining regulatory approval, and by accompanying them through to the start of sales of medical devices developed in Japan. Through this business alliance, the two companies will cooperate with each other to overcome the difficult phase for venture companies, which has been called "Death Valley" in medical device development, by mutually introducing customers. The alliance will also help NCI to achieve its goal of establishing MERV JAPAN (https://www.merv.jp) as soon as possible, thereby improving and promoting the medical device development environment in Japan and striving to bring better medical devices to the clinical stage as soon as possible. MERV JAPAN is a medical device promotion organization (MERV JAPAN: ).