01. Experts with hands-on regulatory experience

Our consultants are "experts with practical experience," including those who have worked in medical device reviews at the PMDA, those who have worked on new developments at medical device manufacturers, and those who have supported clinical trials at medical institutions.

Our distinctive feature is our highly specialized support, including regulatory affairs and insurance reimbursement strategies, from a variety of perspectives.

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02. Support across all clinical areas and product types

We have extensive experience across various clinical fields and specialize in handling unprecedented new medical devices.

We support not only existing medical device manufacturers, but also companies entering the medical device industry for the first time, such as startups, venture companies, venture capital firms (VCs), trading companies, and sales companies.

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03. Comprehensive regulatory support for commercialization

We provide comprehensive support for the regulatory requirements necessary to bring medical device to market, including developing strategies encompassing insurance reimbursement, assisting with the preparation of regulatory submission documents, and providing support at each stage—from nonclinical studies and clinical trials to regulatory submissions.

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