Our Philosophy
The official emblem of a Japanese Certified Administrative Procedures Legal Specialist features the cosmos flower. Etymologically, “cosmos” derives from the Greek “Kosmos”—signifying a beautifully ordered and harmonious system, the absolute antithesis of “Chaos.”
Now entering its 41st year, our firm is built upon the “order of trust” established by the founder—the father of the current Managing Partner—through decades of sincere and dedicated practice under this very emblem.
Today, the business environment surrounding healthcare and advanced medicine is in the midst of “Chaos,” a landscape where explosive technological evolution intertwines with highly complex legal regulations.
Our Principal bridges the micro-systems of life (as an M.D. and Ph.D.) with the macro-ecosystems of business and law (as a J.D. and MBA). Inspired by a childhood fascination with Carl Sagan’s masterpiece, Cosmos, and a profound appreciation for the “harmony of grand systems,” our mission is clear: to design the optimal legal and regulatory order (Cosmos) ensuring that your innovative technologies and ideas seamlessly harmonize with society.
Building on the Principal’s medical expertise and practical experience in Medical Affairs within the pharmaceutical industry, our firm provides focused legal and administrative support for the healthcare and life sciences sectors, helping clients move their businesses forward with clarity and precision.
In particular, we provide support for complex regulatory matters and PMDA (Pharmaceuticals and Medical Devices Agency) interactions through issue spotting, document preparation, and assistance with pre-consultations. We also offer legal support in the medical and healthcare sectors in areas such as contract practice, document development, and compliance. From helping overseas companies enter the Japanese market to supporting domestic companies and medical institutions in advancing their businesses, we work alongside our clients so that their innovative businesses can be appropriately implemented in society and move forward swiftly and steadily.
What Sets Us Apart
1. A multidisciplinary approach based on medicine, law, and business
The firm’s principal holds four advanced professional degrees—an M.D., Ph.D., J.D., and MBA—and takes a panoramic view that integrates the realities of clinical practice, the rigor of academia, the framework of laws and regulations, 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.
Principal Profile
Name Kaoru Okuizumi
Overview With 35 years of clinical experience, he has published two first-author papers in Nature Genetics based on his research in molecular genetics. He is currently in his 14th year of professional practice in the pharmaceutical industry and has developed substantial knowledge and practical experience in the areas of regulation and compliance.
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 principal 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 principal’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
Principal: Kaoru Okuizumi, MD, PhD, JD, MBA (Certified Administrative Procedures Legal 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)