Greeting
Our firm is built upon a 41-year legacy of trusted legal and administrative practice established by our founder.
Today, drawing on my extensive background in both clinical medicine and the pharmaceutical industry, I specialize in providing strategic legal and regulatory support tailored for the healthcare and life sciences sectors.
Leveraging our deep knowledge in complex regulatory affairs and PMDA submissions, we strive to accelerate your business operations, supporting everything from the market entry of overseas companies to the legal needs of domestic firms.
What Sets Us Apart
1. A multidisciplinary approach based on medicine, law, and business
The Representative holds qualifications as a Physician (M.D.), Ph.D. in Medical Science, Juris Doctor (J.D.), and Master of Business Administration (MBA), enabling a comprehensive view of clinical realities, academic logic, regulatory frameworks, and business strategy. We design optimal solutions to help complex healthcare businesses succeed, working alongside executives as a committed partner toward shared goals.
2. Translating across disciplines into a “common language”
Advancing healthcare businesses requires close collaboration among professionals with diverse backgrounds—physicians, researchers, attorneys, and executives. Our office serves as a translator among these specialized “languages.” From business concept development to real-world implementation—including administrative procedures and contract practice—we provide end-to-end support.
3. Decision support to accelerate business execution
We help move projects forward by organizing regulatory requirements and expert opinions. By simultaneously verifying medical evidence and legal consistency and structuring issues multidimensionally with risk and return in mind, we accelerate strategic decision-making. We collaborate with experts in relevant fields as needed, forming a team to design a structure that aims to keep your business moving without interruption.
Representative Profile
Name Kaoru Okuizumi
Overview With 35 years of clinical experience, the Representative has published two first-author papers in Nature Genetics based on molecular genetics research. He is currently in his 14th year at a pharmaceutical company and is well-versed in regulatory and compliance matters.
Licenses / Degrees Certified Administrative Procedures Specialist / Physician / Ph.D. in Medical Science / Juris Doctor (J.D.) / MBA
Certifications and Credentials Board-Certified General Internist (Japanese Society of Internal Medicine) Board-Certified Neurologist (Japanese Society of Neurology) Designated Physician for Intractable Diseases Regulatory Science Expert (Certified by the Japan Society of Regulatory Science) MIT Sloan Executive Certificate (Intelligent Organizations)
Education M.D., Niigata University School of Medicine / Ph.D., Graduate School of Medical Science, Niigata University / J.D., Chuo University Law School (Graduate School of Law) / MBA, NUCB Business School (Nagoya University of Commerce & Business)
Key Professional Experience Niigata University Medical & Dental Hospital; Akita Red Cross Hospital; National Saigata Hospital; Toyama Prefectural Central Hospital; Niigata City General Hospital; JSPS Research Fellow (Brain Research Institute, Niigata University); Sanofi K.K.; Japanese pharmaceutical company (current position)
Office Practice (Areas of Practice) Regulatory compliance and licensing/permits for medical and healthcare businesses (healthcare regulatory practice) Drafting and structuring documents concerning rights and duties (e.g., contracts) (preventive legal practice) Preparation of documents certifying facts For details, please see our “Services” page.
Background & Expertise Medical and scientific assessment: Based on expertise in general internal medicine, neurology, emergency/critical care, home-visit medicine, molecular genetics, and clinical research Legal reasoning and design: Logical structuring grounded in systematic legal studies; regulatory science; strategic preventive legal practice Management and implementation: Cross-disciplinary business design and organizational management
Important Notice (Limitations on Engagements) The Representative is currently employed by a pharmaceutical company. For compliance and conflict-of-interest prevention, we may be unable to accept the following matters. In particular, for the time being, we do not accept engagements from pharmaceutical companies or pharmaceutical development support providers (e.g., CROs).
- Engagements from pharmaceutical companies and pharmaceutical development support providers (e.g., CROs) (not accepted for the time being)
- Matters involving the Representative’s current employer, related companies, or their counterparties where there is a potential risk of conflict of interest or breach of non-compete obligations (acceptance will be determined after reviewing the details)
- Matters reserved exclusively for attorneys under the Attorney Act (e.g., representation in litigation, contentious negotiations, or agency in disputes; we will coordinate with attorneys as needed)
For details, please refer to the “Services” page.
Office Information & Access Office Name: Okuizumi Administrative Legal Office Representative: Kaoru Okuizumi (Certified Administrative Procedures Specialist) Address: 7F Aqua Hakusan Building, 1-13-7 Hakusan, Bunkyo-ku, Tokyo 113-0001 (Meetings are by appointment only, primarily online.)
Contact: Phone: +81-3-6820-5271 Email: contact@okuizumi-office.com In principle, please contact us via the [Contact Form]. (As we may be unavailable during working hours or while traveling, we prioritize inquiries via the form.)
Business Hours: Monday to Friday, 10:00 AM – 5:00 PM (Weekend and evening appointments are by prior arrangement only.)
Affiliation: Tokyo Administrative Procedures Legal Specialist Association, Bunkyo Branch (Registration No.: 26080541)