医療系ベンチャー・トータルサポートオフィス：MEDISO ( Medical Innovation Support Office )

2026年8月8日（土）～2026年8月17日（月）は、休業とさせていただきます。
この期間中にお受けしたお問い合せ・ご相談の申込みについては、休業明けに対応させていただきます。
何卒ご了承のほどお願いいたします。

What is MEDISO

MEDISO provides support for business ventures, academia,
and individuals intending to put into practical use medicines,
medical devices, and regenerative medicinal products.
Click here for further details.

About the Medical Innovation Support Office

The medical innovation support office matches medical venture companies and academic institutions facing challenges in the practical application of medical products and devices for specialists* who provide detailed consultation and support for solving problems at each stage from research and development to practical use, as well as insurance coverage at clinical sites, while looking ahead to the overall comprehensive advances and dissemination into the global market.
* Specialists in each field provide support for the response to laws and regulations, marketing, business planning, fund rasing, management strategy, intellectual property management, and international development, etc.

This website is operated by Mitsubishi Research Institute, Inc., as a trustee under instructions from the Economic Affairs Division, Health Policy Bureau, and Ministry of Health, Labour and Welfare as a part of the total support for the medical ventures program sponsored by the Ministry of Health, Labour and Welfare.

Support targets

Ventures, academic institutions, and individuals aiming to put into practical use the medicines, medical devices, regenerative medicinal products, and novel drug-discovery technologies or medical materials subject to the Pharmaceuticals and Medical Devices Law.

Details of support

MEDISO provides support for the practical application of medicines, medical devices, regenerative medicinal products, and other products subject to the Pharmaceuticals and Medical Devices Law.
That support includes business planning, financing, advice on laws and regulations, and other assistance as required.

●Support method：We provide support via online meeting or e-mail.
●Support source：Support is provided in cooperation with experts in R&D, consultants in pharmaceutical affairs, and experts from related organizations including the Ministry of Health, Labour and Welfare.
●Remarks：Consultation and support services are free of charge.

Click here for inquiries

In case the link does not work, please contact us at the email address below
mediso@ml.mri.co.jp

Specialists Introduction

We will introduce registered specialists
(updated as necessary).

Akiko Yamamoto

Nissan Chemical Corporation
Risk Management ＆Compliance Office
Risk Management Department

Main specialty areas

medicines

Specialized support fields

Regulatory compliance
Business operation systems
Etc

Graduated from the Department of Pharmacy at Kyoritsu Collage of Pharmacy (currently Keio University) and received a Ph.D. from Gifu Pharmaceutical University. Engaged in work related to each process of pharmaceutical life cycle (research and development, sales promotion, licensing/alliance, quality assurance and Good Vigilance Practice(GVP)) at Nissan Chemical Corporation. Especially, as the corporate quality assurance department leader, managed the company's pharmaceutical quality system, and maintained and improved appropriate quality assurance systems for API manufacturing sites, manufacturing contractors, and contract testing facilities. Specifically, provided support during FDA inspections and global pharma quality audits, and advised on improvements and response policies for issues raised. Also has experience in implementing regulations and change processes when adding starting material, intermediate and API manufacturing sites, and testing facilities. In addition, has reviewed documents such as license and quality assurance-related contract contents, change applications and master files to be submitted to authorities.

Kensuke Suzuki

Nagashima Ohno & Tsunematsu
Partner, Attorney-at-law

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Funding
Business operation systems
Specialized support fields

Kensuke Suzuki is a partner at Nagashima Ohno & Tsunematsu. He represents both domestic and international clients, with a special focus on cross-border transactions, with respect to pharmaceutical, medical and healthcare business, M&A and corporate transactions, fund formation and management, and financial regulations. With expert knowledge of the Japanese medical, pharmaceutical, medical device, and other various healthcare-related regulations, he advises on a wide variety of business activities in the broad healthcare sector, such as regulatory compliance, data protection, mergers and acquisitions, alliances, business startups, financing, licensing and other commercial transactions. He was admitted to the Japan Bar in 2000 and worked as visiting attorney at Kirkland & Ellis （Chicago） from 2006 to 2007. He served as a special adviser to the Ministry of Health, Labour and Welfare from 2014 to 2015. He is fluent in Japanese and English.

Saaya Hirai

Globizz Corp.　Senior Manager

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Marketing
Business planning
Business operation systems

After graduating from a university in Taiwan, she began her career at Globizz Japan as a Business Planning Specialist. In this role, she developed proposals for Japanese companies seeking entry into the U.S. market and provided support for FDA compliance, including assistance with Quality Management System (QMS) development for medical device manufacturing facilities and FDA inspection readiness. She later transitioned to Globizz Corp., the U.S. headquarters of Globizz Japan, where she currently coordinates FDA submission projects and conducts regulatory research and registration activities. In addition, she supports Japanese companies in expanding their presence in the U.S. medical device market by accompanying them to major industry exhibitions, assisting with trade show participation, and joining business meetings to facilitate market development. Leveraging her proficiency in English, Japanese, and Chinese, she plays a key role as a bridge in international projects. Her support experience includes FDA submission strategy development, 510(k) submissions, Breakthrough Device designation requests, U.S. KOL interviews, reimbursement strategy support, and assistance with establishing U.S. corporate entities.

Chia-Feng Lu

Shareholder(Senior Partner), Greenberg Traurig, LLP

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Funding
Business operation systems
Specialized support fields

Chia-Feng Lu represents life sciences companies and industry associations in strategic regulatory and legislative worldwide to guide and develop new legislation and policy, to frame effective approaches to working with the various agencies on compliance and investigation issues. He has intensive experience in provision of the guidance to companies introducing novel technology products, such as AI, block chain, 3D-printing, cancer immunotherapy, digital health, cell / gene therapy, precision medicine-related products and services, RNAi drug, as well as SMART device. In his past experience, he has already assisted companies in translating the scientific ideas from Nobel Laureates into the successful commercial launch of at least two products. In addition, he advises investment banks, private equity firms, and venture capital groups on their evaluations of the technologies, deal structures, and the resulting business impacts, as well as regulatory uncertainty with respect to novel technology and compliance. He specializes in various issues in connection with biotech investors or life sciences companies’ research & development strategy, portfolio management, corporate strategy planning, partnerships, licensing, project finance, auction, investment, and M&A. He has also served as an adjunct faculty member of a number of leading academic institutions in the U.S. and Japan, and an advisor to numerous government agencies.

Miyuki Nagao

Globizz Japan Corporation　Tokyo Office Director

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Marketing
Business planning
Business operation systems

After graduating from a U.S. university, she began her career at Globizz Corp., the U.S. headquarters of Globizz Japan, where she was engaged in FDA registrations and regulatory research across the medical device, pharmaceutical, and food sectors. Through her involvement in a wide range of projects for international clients, she cultivated substantial, practice based expertise in FDA regulatory compliance. She subsequently joined Globizz Japan and currently serves as a Project Coordinator at the Tokyo office. In this capacity, she develops and proposes tailored support plans for companies seeking entry into the U.S. market, while overseeing comprehensive project coordination between U.S.-based consultants and clients. By working closely with a team of subject matter experts—including FDA consultants at the U.S. headquarters—she delivers highly precise and effective regulatory support. Drawing on her direct experience participating in FDA inspections, she also provides on site inspection assistance and collaborates with specialists to offer practical services, including interpretation support, Quality Management System (QMSR) development, Form 483 response preparation, and CAPA planning.

About details of specialists

Introduction of measures implemented by public institutions

We will describe the measures from public institutions for pharmaceutical companies,
medical device companies, companies manufacturing regenerative medicinal products, and venture companies.

See more about measures implemented by public institutions