About

Greeting

Message from the Representative

Our office is a healthcare-focused Administrative Procedures Office led by an Administrative Procedures Legal Specialist and physician (M.D./Ph.D./J.D./MBA) who integrates expertise in medicine, science, law, and business to connect healthcare enterprises, clinical practice, and Japan’s administrative and regulatory systems.

The official emblem of Japan’s Administrative Procedures Legal Specialists is the cosmos flower. The word “cosmos” derives from the Greek Kosmos, meaning an ordered and harmonious universe, and is traditionally contrasted with Chaos.

Our office is now in its 41st year since its founding. Its foundation is the “order of trust” established by the founder, my father, through many years of sincere and conscientious professional practice under this emblem.

Today, healthcare and advanced medicine operate in a business environment where rapidly evolving technologies intersect with increasingly complex laws and regulations—a landscape that may truly be described as being in the midst of Chaos.

As a clinician and medical researcher, the current principal has explored the microscopic systems of human life. At the same time, through Medical Affairs work in the pharmaceutical industry, he has gained practical experience involving medicines, clinical research, healthcare data, and healthcare delivery systems. He has also studied law and business, developing a broader perspective on the macroscopic ecosystems of business and society.

Through clinical practice, scientific research, and work in the pharmaceutical industry, he came to recognize that challenges in healthcare are rarely medical issues alone. They are often closely connected with laws and regulations, administrative systems, organizational governance, and the design and use of professional documentation. He therefore rebuilt the administrative procedures practice inherited from his father as a healthcare-focused office integrating the knowledge and experience he had developed across medicine, science, law, and business.

Healthcare operates within rigorous regulatory and institutional frameworks. Our office designs the legal, institutional, and business structures needed for innovative technologies and ideas to achieve responsible and harmonious implementation in society.

Our work encompasses medical AI, SaMD, medical devices, HealthTech, real-world data and healthcare data, the operation, succession, and M&A of healthcare institutions, and the preparation of explanatory materials, contracts, and other legal and administrative documents. Drawing on medical, legal, and business perspectives, we carefully identify and organize the relevant facts and issues and design reliable procedures to support responsible implementation.

Behind every healthcare system, business initiative, and professional document are patients living with illness or disability and the families who support them. Our practice is grounded in the belief that improving complex systems and businesses should ultimately contribute to safer, more appropriate healthcare and support.

We also provide ongoing support to individuals and families facing illness or disability. By organizing the relevant facts and records concerning medical care, long-term care, and administrative matters that are still in progress, and by preparing necessary documents and consultation materials, we help clients connect with appropriate healthcare institutions, public authorities, and other professionals.

Our Role

In healthcare, even excellent technologies and ideas do not automatically reach social implementation.

Healthcare businesses are shaped by numerous overlapping systems, including the Medical Practitioners’ Act, the Medical Care Act, the Pharmaceuticals and Medical Devices Act, personal information protection laws, medical advertising regulations, online medical consultation rules, pharmacy and long-term care regulations, PMDA and other administrative consultations, research ethics, and contract practice.

In addition, physicians, researchers, pharmacists, nurses, executives, engineers, attorneys, patent attorneys, administrative authorities, and investors often use different language and focus on different priorities.

Our office helps design a common language and an implementable order within this complex healthcare environment by organizing medical validity, regulatory issues, administrative procedures, business implementation, and documentation as an integrated whole.

Our support is not limited to document preparation. Even when a business concept or consultation topic is still unstructured, we can listen to the current idea and help identify key issues, matters to be confirmed, the need for administrative consultation, the need for collaboration with other professionals, and the next practical steps.

Furthermore, we believe that clarifying the relevant facts and supporting grounds, and structuring dialogue among the parties in a manner that permits objective review, contributes both to the smooth implementation of administrative procedures and to the realization of the rights and interests of individuals. We therefore regard supporting the proper and transparent operation of systems in the medical and healthcare fields—through both documentation and constructive dialogue—as one of the social roles of our office.

Features of the Office

1. A Multidisciplinary Approach Combining Medicine, Law, and Business

The representative holds four advanced professional backgrounds: physician (M.D.), medical scientist (Ph.D.), legal professional training (J.D.), and business management (MBA).

This enables the office to take a comprehensive view of clinical realities, academic reasoning, regulatory frameworks, and business strategy.

We design practical solutions for complex healthcare businesses and support executives as a professional partner working toward the same goal.

2. Translation into a Common Language Across Disciplines

Healthcare implementation requires collaboration among people from different professional backgrounds, including physicians, researchers, attorneys, executives, engineers, administrative authorities, and investors.

Our office translates the language of each field into a shared working language.

We connect medical background, regulatory issues, administrative procedures, contract practice, and business decision-making, supporting clients from the concept stage through practical implementation.

3. Decision-Making Support to Accelerate Business Progress

We help move projects forward by organizing regulatory issues and expert opinions.

By simultaneously examining medical evidence and legal consistency, and by structuring risks and returns in a multidimensional way, we support faster and more strategic management decision-making.

Where necessary, we collaborate with experts in relevant fields and build teams designed to keep the business moving.

Main Service Areas

1. For Corporate Clients

Commercialization Support for Medical AI, SaMD, HealthTech, RWD, and Medical Device Companies

We support medical AI, SaMD, medical device software, HealthTech, real-world data and healthcare data businesses, genomic medicine, regenerative medicine, gene therapy, telemedicine platforms, and healthcare SaaS services.

Our support includes early-stage issue mapping, medical device applicability, the Pharmaceuticals and Medical Devices Act, the Medical Practitioners’ Act, medical advertising regulations, personal information protection, preparation for PMDA and administrative consultations, and preparation of explanatory documents, informed consent documents, contracts, and terms of use.

We also assist foreign companies entering the Japanese market, VC/CVC firms and their portfolio startups, university spinouts, and R&D-based ventures with medical, regulatory, administrative, and documentation-related support.

2. For Medical Institutions, Pharmacies, and Long-Term Care Facilities

Operational, Succession, Licensing, and Governance Support

We support hospitals, clinics, medical corporations, pharmacies, long-term care facilities, home medical care providers, and long-term care service operators with opening, change, closure, succession, M&A, licensing management, administrative procedures, contracts, explanatory documents, advertising, medical safety, institutional governance, interprofessional collaboration, and patient/family-facing documentation.

We also support licensing schemes for medical, long-term care, and pharmacy M&A, public health center and regional health bureau procedures, administrator changes, notification management, post-merger integration procedures, pharmacy DX, online medication guidance, specimen measurement rooms, and collaboration with medical institutions.

3. For Professionals, Advisors, and Investors

Medical, Regulatory, and Administrative Translation Support

We support attorneys, patent attorneys, certified public accountants, tax accountants, certified social insurance and labor consultants, M&A advisors, VC/CVC firms, and new business divisions of corporations by organizing medical background, regulatory structures, administrative procedures, and practical realities of healthcare settings.

This support may assist with case understanding, investment review, contracts, licensing, and preparation for administrative consultation.

When dispute representation, investment decisions, formal legal opinions, intellectual property strategy, or other specialized matters are required, we coordinate with attorneys, patent attorneys, certified public accountants, tax accountants, certified social insurance and labor consultants, and other professionals as appropriate.

4. For Physicians, Healthcare Professionals, and Individuals

Fact Organization and Administrative Consultation Preparation Related to Healthcare Practice

From the perspectives of both a physician and a certified administrative procedures legal specialist, we support the organization of facts, timelines, issues, supporting materials, and explanatory documents related to physician name use, medical records, prescriptions, medical safety, labor issues, healthcare facility operations, patient and family explanations, and consultation or information provision to administrative authorities.

We do not provide dispute representation or negotiate with opposing parties. Where necessary, we coordinate with attorneys, certified social insurance and labor consultants, medical safety experts, labor experts, and administrative response specialists.

Representative Profile

Kaoru Okuizumi, MD, PhD, JD, MBA, Certified Administrative Procedures Legal Specialist

Career and Achievements

Dr. Okuizumi has 35 years of clinical experience as a physician, including extensive practice in neurology, dementia, stroke, and general internal medicine. In the field of molecular genetics, he has published two first-author papers in the internationally renowned scientific journal Nature Genetics.

He is currently in his 14th year of corporate practice in the pharmaceutical industry, where he has gained advanced knowledge and practical experience in Medical Affairs, regulatory science, compliance, clinical research, RWD/RWE, and healthcare business operations.

Formative Experiences and Professional Approach

From an early age, Dr. Okuizumi was deeply inspired by Carl Sagan’s landmark work Cosmos and captivated by the harmony of vast and complex systems. His fascination with the idea that complexity can exist not as disorder, but as a coherent and ordered whole, has continued to shape both his learning and his professional work. It is also closely connected to his present mission: designing the legal, institutional, and business “order” required for innovative healthcare technologies and ideas to function in harmony with society.

At the same time, this interest was never confined to abstract systems. Dr. Okuizumi grew up in a family that had been engaged in farming and forestry for generations in a mountainous area within one of Niigata Prefecture’s heavy-snowfall regions. His father was involved in farming and forestry while also working as an Administrative Procedures Legal Specialist. In the local community, accidents and injuries associated with agricultural work, forestry, and winter snow-removal activities sometimes required emergency transport. Although the community had a local clinic, advanced diagnostic and treatment capabilities were concentrated in urban medical institutions, and transport to such facilities required considerable time. There were also cases in which local residents died while being transported for emergency care. From childhood, he was therefore keenly aware, through everyday life, of regional disparities in access to healthcare.

Had online medical consultation, telemedicine, medical information sharing, diagnostic support technologies, and other forms of digital transformation in healthcare been implemented at an earlier stage, access to healthcare in such communities might have looked very different. This awareness is one of the motivations underlying his work in supporting the real-world implementation of healthcare digital transformation, SaMD, medical devices, and HealthTech.

Outstanding technologies and ideas do not create value merely by existing. They acquire meaning in society only when they are shaped into forms that can genuinely reach the people who need them—through appropriate institutional frameworks, administrative procedures, real-world operations, clear explanatory documentation, and consensus-building among relevant stakeholders.

His later research in molecular genetics developed his early interest into a rigorous inquiry into the structures and order underlying biological phenomena. It also provided an opportunity to cultivate a disciplined methodology for reassessing complex questions on the basis of objective facts. Rather than accepting established theories or conventional assumptions as given, he learned to return to observed facts and test multiple hypotheses. This approach continues to inform his professional practice today.

In complex matters involving healthcare and life sciences, he places particular importance on looking beyond customary practices and formal explanations, confirming the relevant facts through objective documentation, and reassessing the underlying structures and relationships that shape the issue.

Dr. Okuizumi’s family lineage is connected to retainers of the Uesugi clan, and a tradition of valuing justice, principle, and proper conduct has been passed down through the family. As symbolized by the historic “Naoe Letter” written by Kanetsugu Naoe, clearly articulating one’s position through words and written documents, and presenting a reasoned and principled case, is not merely a matter of writing technique. It represents a fundamental professional approach.

This approach is not intended to create unnecessary confrontation. Rather, it serves to clarify facts and issues, establish a shared basis for discussion among the parties concerned, and enable constructive dialogue and consensus-building.

Drawing on these formative experiences, analytical methods, and professional principles, Dr. Okuizumi carefully organizes complex facts and issues, accurately documents each client’s vision and position, and supports the real-world implementation of healthcare businesses and innovations through constructive dialogue and consensus-building with administrative authorities and relevant professionals. His aim is to help valuable healthcare technologies and ideas take practical form and reach the people who genuinely need them.

Areas of Expertise and Value Delivered

Dr. Okuizumi integrates expertise in neurology, including dementia and stroke, general internal medicine, molecular genetics, genomic medicine, Medical Affairs, clinical research, healthcare data and real-world data (RWD), as well as medical devices, Software as a Medical Device (SaMD), and HealthTech.

Drawing on experience in outpatient, inpatient, emergency, and home-visit care, he also places particular emphasis on operational design, patient safety, and regional healthcare coordination—factors essential to ensuring that healthcare technologies and systems function effectively in real-world clinical settings.

By combining the medical and scientific expertise of a physician (M.D./Ph.D.) with perspectives in law and management (J.D./MBA), he provides robust support for regulatory analysis, administrative procedures, and legal documentation essential to the real-world implementation of healthcare businesses and innovations.

Professional Qualifications and Academic Degrees

• Administrative Procedures Legal Specialist / Physician
• Ph.D. in Medicine / J.D. / Master of Business Administration (MBA)

Certifications

• Board-Certified General Internal Medicine Specialist, Japanese Society of Internal Medicine
• Board-Certified Neurologist, Japanese Society of Neurology
• Designated Physician for Intractable Diseases
• Regulatory Science Expert, certified by the Japanese Society of Regulatory Science
• MIT Sloan Executive Certificate in Intelligent Organizations

Professional Affiliations

• Member, Japan Stroke Society
• Member, Japan Pharmaceutical Support Professionals Association

Education

• Niigata University School of Medicine
• Graduate School of Medicine, Niigata University
• Chuo University Law School
• Graduate School of Management, Nagoya University of Commerce & Business

Selected Professional Experience

• Niigata University Hospital
• Akita Red Cross Hospital
• National Saigata Hospital
• Toyama Prefectural Central Hospital
• Niigata City General Hospital
• Research Fellow, Japan Society for the Promotion of Science, at the Brain Research Institute, Niigata University
• Sanofi K.K.; and a Japanese pharmaceutical company, where he currently serves.
  For a more detailed professional background and the latest updates, please visit Dr. Okuizumi’s LinkedIn profile.

Engagement Policy

Our office accepts consultations from the early stages of healthcare and medical business planning, even when the business concept or issues have not yet been fully organized.

Examples include:

• You are considering a medical AI, SaMD, or HealthTech business but are unsure whether it may be treated as a medical device.
• You are considering a new business using pharmacies or medical institutions but are unsure which regulations may apply.
• You wish to utilize RWD or healthcare data but need to organize issues related to personal information, consent, research use, and business use.
• You wish to consult PMDA or another administrative authority but are unsure what to prepare or in what order.
• You need to organize licensing or notification issues in connection with the succession or operation of a medical institution, pharmacy, or long-term care facility.
• You need to prepare or review materials, explanatory documents, informed consent documents, contracts, terms of use, or advertising materials in the healthcare field.
• As an attorney, patent attorney, M&A advisor, VC/CVC firm, or business corporation, you need medical or regulatory issue mapping for a healthcare-related matter.

In an initial consultation, we listen to the current business concept, issues, materials, stakeholders, and planned services, and help organize key issues, possible administrative procedures or licenses, the need for collaboration with other professionals, and the next steps.

If specific research, document preparation, administrative consultation preparation, preparation of contracts, explanatory documents, informed consent documents, or ongoing advisory support is required, we provide a separate estimate.

Engagement Restrictions and Conflict-of-Interest Management

The representative is currently employed by a pharmaceutical company. Accordingly, from the perspectives of compliance and conflict-of-interest management, certain engagement restrictions apply.

For details, please refer to the “Services” page.

Office Information