Navigate regulation. Accelerate healthcare.

We primarily serve corporate clients developing medical businesses—such as HealthTech, MedTech, and Regenerative Medicine. We provide comprehensive support ranging from strategic planning to the administrative procedures and legal documentation required for the actual sites (medical institutions, etc.) where these businesses are implemented.

Led by a Certified Administrative Procedures Legal Specialist with a background in Medicine (MD) and Molecular Genetics (PhD), we propose optimal procedural designs and documentation from both “business implementation” and “clinical introduction” perspectives.

Note: Please consult us even if your specific case is not listed below. We offer customized solutions tailored to your needs and coordinate with other specialists as required.

1. New Business, Private Practice, VC/CVC & Startup Support

– Supporting procedures and documentation to “socially implement” ideas in compliance with regulations

We support the launch of new ventures in HealthTech, MedTech, and Drug Discovery. We also assist with the establishment and application procedures for medical institutions, nursing facilities, and pharmacies introducing non-insured treatments (e.g., regenerative medicine, gene therapy), and provide regulatory due diligence for VCs/CVCs.

• Startup Support, Licensing & In-bound Market Entry
  • Support for obtaining necessary licenses to commence business, such as “Marketing of Specially Controlled Medical Devices,” and designation of medical/nursing care institutions.
  • Establishment and redesign of Japanese subsidiaries for foreign companies (addressing unexpected issues during market entry).
  • Drafting Articles of Incorporation tailored for medical business objectives.
  • Visa applications for management (Business Manager Visa, etc.).
• Regulatory Analysis & Government Consultation (For Enterprises)
  • Regulatory requirement analysis for new services (Apps, SaaS, Medical AI/SaMD, Genome Analysis) under the Medical Practitioners’ Act, PMD Act, and AI Guidelines.
  • Preparation of materials for prior consultation with administrative agencies and support for the “No-Action Letter” system.
• Regenerative Medicine & Gene Therapy Implementation
  • Support for accreditation and notification of Regenerative Medicine Provision Plans (Class I & II) for gene therapy, cancer immunotherapy, etc.
  • Scientific Rationale Development: Organizing arguments based on molecular mechanisms and establishing implementation structures.
  • Application support for Specified Cell Processing Facilities (CPC).
• Regulatory & Medical Due Diligence (For VC/CVC)
  • Fact-finding, issue organization, and documentation regarding medical and pharmaceutical regulations (PMDA, etc.) necessary for investment consideration in the Bio/Healthcare sector.
  • Note: We do not provide advice or agency services regarding investment decisions, valuation, terms, or expected returns.
• Public Funding (AMED, NEDO, etc.) Acquisition Support for R&D Startups
  • Support for drafting business plans and grant applications that logically demonstrate scientific validity and innovation for R&D grants, such as AMED (Japan Agency for Medical Research and Development) and NEDO.
  • Evidence construction and comprehensive literature reviews to clearly demonstrate medical and technical validity.
• Next-Gen Pharmacy & Healthcare Hub Modeling
  • Legal organization and notification support for Online Medication Guidance and Sample Measurement Rooms.
  • Risk diagnosis for Pharmacy DX (delivery coordination, app utilization) under the PMD Act and Personal Information Protection Act.
  • Note: For requests from major pharmacy chains involving joint research partners, we may decline based on conflict of interest management. Please inquire for details.

2. M&A (Business Succession), Corporate Legal & Operations

– Supporting stable business operations and smooth transitions

We support the construction of regulatory schemes for Business Succession (M&A) of active healthcare companies, hospitals, clinics, nursing facilities, and pharmacies. We also handle the drafting of various contracts and administrative procedures required for daily operations.

• Medical/Nursing M&A & Business Succession Support
  • Formulating Succession Schemes: Designing the logic for “discontinuation and new establishment” procedures with Public Health Centers and Bureaus of Health and Welfare to prevent operational gaps during changes of establishers or incorporation.
  • Administrative Legal Due Diligence (DD): Risk diagnosis of the target facility’s compliance status (personnel standards, structural standards, advertising regulations, etc.) and proposal of corrective measures.
  • Post-Merger Integration (PMI): Complete agency service for changing administrators, bed notifications, and rewriting various designations (public expense, workers’ compensation, etc.) after the succession.
• Contract Drafting & Review
  • Drafting of Service Agreements, System Usage Agreements, Non-Disclosure Agreements (NDA), Joint Research Agreements, etc.
  • Legal check of employment contracts and rules of employment for medical/nursing institutions (in coordination with partnering Social Insurance Labor Consultants).
• Administrative Procedures (Operations Management)
  • Preparation and submission of periodic reports, change notifications, and business reports to administrative agencies.
  • Procedures for license rewriting or changes due to changes in officers, office relocation, or change of administrators.
• Advertising & Compliance Review
  • Regulatory review of websites, landing pages (LPs), and flyers against the Medical Care Act (Medical Advertisement Guidelines), PMD Act, and Act against Unjustifiable Premiums and Misleading Representations.

3. Medical Advisory for Professionals

– Supplementing medical and regulatory literacy for Lawyers, Tax Accountants, and Consultants

We provide expert insights and documentation support from the perspective of a Certified Administrative Procedures Legal Specialist and MD to law firms, accounting firms, and consulting firms handling cases that require advanced medical knowledge, molecular genetics expertise, or interpretation of pharmaceutical regulations.

• Opinion Letters on Legality & Safety of New Businesses
  • Evaluation of medical safety and compliance with Article 20 of the Medical Practitioners’ Act (prohibition of treatment without examination) for Telemedicine/Online Medical schemes.
  • Legal and medical interpretation regarding the boundary between “Medical Practice” and “Health Consultation” in Healthcare AI and SaMD.
  • Safety evaluation of unapproved devices used in beauty/wellness businesses and risk diagnosis regarding the Medical Practitioners’ Act.
  • Opinion letters on risk classification of processed cells and scientific validity of provision plans under the Act on the Safety of Regenerative Medicine.
• Joint Acceptance & Spot Support for Advanced Medicine
  • Joint acceptance of license applications requiring high-level scientific knowledge, such as gene therapy and clinical research using viral vectors.
  • Scientific validity checks of protocols and informed consent documents from the perspective of a Molecular Geneticist.
  • Advisory and training on advanced medical law for other professional firms.
• Evidence Construction & Fact-Finding
  • Product Liability (PL) Defense & Corporate Legal Support: Comprehensive systematic reviews of medical literature regarding causality between pharmaceuticals/medical devices and health damage. Preparation of investigation reports demonstrating medical validity.
• Support for M&A Professionals
  • Investigation and reporting on compliance status with the Medical Care Act and PMD Act during business succession (M&A) considerations.
  • Analysis of license transferability, administrative sanction risks, and legal organization of remediation schemes.

Collaboration with Other Professionals

To ensure the optimal solution for your needs, we collaborate with trusted Lawyers, Tax Accountants, Administrative Procedures Legal Specialists, and Social Insurance Labor Consultants for matters outside the scope of an Administrative Procedures Legal Specialist (e.g., legal disputes/litigation, tax filing, corporate registration, labor management). For large-scale projects or specific specialized fields, we form teams with partnering Administrative Procedures Legal Specialists to build a system that ensures quality without halting your business speed.

⚠ Important Notice (Compliance & Conflict of Interest)

The representative of this office is currently employed by a pharmaceutical company. To strictly observe compliance and prevent conflicts of interest, we cannot accept the following cases. Furthermore, requests from pharmaceutical companies and Contract Research Organizations (CROs) are currently not being accepted.

1. Requests from Pharmaceutical Companies and CROs:
   • Currently not accepted.
2. Cases involving the representative’s current employer, its affiliates, or their business partners where there is a risk of Conflict of Interest (COI) or breach of non-compete obligations:
   • Acceptance will be determined after confirming the details of the request.
3. Duties restricted to Lawyers under the Attorneys Act:
   • E.g., Acting as an agent in litigation, negotiation of disputes. We will coordinate with lawyers as necessary.

Client information is strictly managed based on the confidentiality obligations of the Certified Administrative Procedures Legal Specialist Act and will not be disclosed to third parties unless required by law.

We will assess whether we can handle your request based on the details provided. Please feel free to contact us via the inquiry form for an initial overview.