MENU

Fees

Pre-Engagement Screening

We provide advance confirmation of feasibility and an estimate of the expected scope of work and costs without requiring a meeting. No fees will be incurred at this stage.

Please submit a brief overview via the inquiry form. After reviewing the details, we will inform you of the feasibility of the matter and provide an estimated cost range.

Fee Structure

To ensure our clients’ peace of mind, our office adopts a fixed-fee quotation system where the scope of work and total fees are clearly presented before the contract is signed. We will not charge additional fees for the agreed-upon scope of work without your prior consent.

Note: If changes or additions to the scope of work arise after the engagement begins, we will consult with you and present a revised estimate for your approval. The fees listed below are standard guidelines. Final estimates may vary based on the nature, complexity, and business scale of each matter.

All prices below include tax unless otherwise noted.

1. Initial Consultation & Spot Consulting

For matters requiring substantive regulatory issue-spotting, legal and administrative analysis, business model risk assessment, or roadmap planning, we provide a paid Initial Strategy Consultation / Spot Consulting session.

We organize current issues, identify regulatory and procedural points, and formulate a roadmap for necessary procedures.
You are welcome to use this service even if your challenges or legal issues are not yet fully defined. During the initial meeting, we will work together through discussion to clarify your concerns and identify the key issues.

Fee: 55,000 JPY (tax incl.) / 50 mins

*Depending on the nature of your consultation, the session length may be adjusted in 10-minute increments at JPY 11,000 (tax included) per 10 minutes.

  • Conducted online (via Zoom, etc.).
  • If you formally engage us for services (such as document creation or license application), this initial consultation fee will be credited toward the project fee.
  • For matters that do not require extensive research, the initial meeting alone may be sufficient to clarify the appropriate course of action. This service may also be used for a one-time question or as a professional second opinion.

    Preliminary confirmation of scope, general fee range, and whether a paid consultation is necessary is handled as a pre-engagement screening step before scheduling a meeting.

2. Document Creation & Licensing Support (Project-Based Fees)

Based on the consultation, we provide a fixed-fee quote for each task. The following are standard guidelines (tax incl.). Fees may vary depending on difficulty and business scale.

Regulatory Analysis & Documentation

We organize key points and create documentation to explain new businesses in compliance with legal requirements.

  • Drafting documents organizing basic facts for investment decisions: From 165,000 JPY
    • Purpose: To organize points from regulatory and procedural perspectives, not to advise on the investment decision itself.
  • Drafting Statements of Reasons / Regulatory Explanatory Materials: From 165,000 JPY
  • Preparation of materials & support for pre-consultation with administrative agencies: From 110,000 JPY

Licensing & Incorporation Procedures

  • Licensing & Notification Support (Medical Devices, Public Funding Designation, etc.): From 165,000 JPY
  • Incorporation Support (Drafting Articles of Incorporation, Notarization): From 110,000 JPY
  • Application for Establishment of a Medical Corporation: From 550,000 JPY

Contracts & Terms of Use

We support the preparation of documents reflecting industry regulations (Medical Care Act, PMD Act, etc.) and risk management, rather than using generic templates.

  • Contract Review: From 165,000 JPY (Depends on volume/difficulty)
  • Contract Drafting (New Creation): From 220,000 JPY
    • We design clauses for dispute prevention and business defense, ensuring consistency between medical/scientific evidence and legal regulations.
  • Drafting Terms of Use & Privacy Policies: From 110,000 JPY

3. Advisory & Ongoing Support (Retainer)

For clients requiring an ongoing partnership, we guarantee priority access to our firm’s resources, ensuring your requests take precedence over ad-hoc consultations.

Monthly Retainer Fee: From 55,000 JPY (tax included)

※Under the retainer agreement, we provide priority strategic advisory on ongoing regulatory, licensing, and operational matters. This encompasses routine email consultations, legal/regulatory document reviews, and continuous support tailored to your business.

Examples of Ongoing Support Under a Retainer Agreement
A retainer agreement provides support beyond one-time consultations or individual document preparation. As a business, product, service, organization, or regulatory project develops, we provide ongoing assistance with issue identification, document development, preparation for consultations with public authorities, and coordination with other professionals.

  • For Medical Device, SaMD, and HealthTech Companies
    We provide ongoing support for medical devices, software as a medical device, medical AI, digital health, HealthTech, and other healthcare products and services throughout the stages of development, commercialization, regulatory consultation, implementation within healthcare institutions, and post-implementation operations.
    As product specifications, intended use, target patient populations, intended users, service delivery models, or business models evolve, we assist in reviewing whether the product falls within the medical device or SaMD regulatory framework, the application of the Pharmaceuticals and Medical Devices Act, the Medical Practitioners’ Act, and other relevant laws, the handling of medical data and personal information, the allocation of responsibilities between companies and healthcare institutions, and the need for consultation with the PMDA or other public authorities.
    We also assist in developing and updating regulatory and administrative roadmaps, consultation materials, product explanations, and related documentation.
    Through the organization of medical and scientific evidence and the preparation or review of materials for physicians and patients, consent documents, implementation materials for healthcare institutions, internal operational and coordination documents, terms of use, and privacy policies, we help identify at an early stage potential gaps between a product developer’s concept and the way the product will actually be used in clinical practice. Our aim is to support the development of systems that facilitate appropriate and responsible implementation in healthcare settings.
    We also provide ongoing review of websites, landing pages, sales materials, press releases, case studies, and other promotional content from the perspective of the Pharmaceuticals and Medical Devices Act, medical advertising regulations, the Act against Unjustifiable Premiums and Misleading Representations, and consistency with the available medical and scientific evidence.
  • For Foreign Healthcare Companies and Companies Entering the Japanese Market
    We provide ongoing support for overseas medical device, diagnostic, SaMD, digital health, medical AI, and other healthcare companies entering or expanding their operations in Japan, taking into account Japan’s healthcare system, regulatory and administrative procedures, clinical practice, and business environment.
    We assist in organizing the regulatory position of a product or service in Japan, the proposed market-entry structure, required licenses, permits, and notifications, the allocation of responsibilities with a marketing authorization holder or other Japanese business partner, the approach to PMDA and other administrative consultations, and arrangements for collaboration with healthcare institutions and local professionals.
    We also assist in developing and regularly reviewing a roadmap and action plan for entry into the Japanese market.
    Our support is not limited to the literal translation of materials prepared by an overseas headquarters. We assist in adapting product information, internal materials, contractual and operational documents, and other communications to Japanese laws, regulatory expectations, healthcare practice, and business customs.
    Where necessary, we coordinate with regulatory, intellectual property, contractual, tax, and other professionals to support the establishment of an appropriate operational structure in Japan.
  • For Medical Institutions, Pharmacies, and Long-Term Care Service Providers
    We provide ongoing support for routine reviews, document development, and operational improvements in areas including communications with public health centers, Regional Bureaus of Health and Welfare, and local governments; licenses, permits, and notifications; medical advertising; explanatory materials for patients and families; medical records, consent forms, and internal operational documents; coordination between home healthcare providers and care facilities; patient safety; and compliance.
    By identifying at an early stage potential misunderstandings with patients and families, problems in internal operations, and deficiencies in legal or regulatory compliance, we help organizations develop systems that contribute to preventing disputes and regulatory findings.
    When regulations change, clinical operations are modified, new healthcare or long-term care services are introduced, or inquiries are received from public authorities, we assist in organizing the relevant facts, required actions, explanations, and documentation in a manner consistent with the realities of clinical practice.
  • For Organizations Following M&A or Business Succession
    Following the acquisition, succession, transfer, or restructuring of a medical institution, pharmacy, long-term care provider, or other healthcare business, we provide ongoing support with licenses, permits, notifications, communications with public authorities, the review of contracts and internal rules, operational documents, business handovers, and the allocation of responsibilities among relevant parties.
    We review existing documentation, operations, and accountability structures to help ensure continuity in clinical services, communications with patients and families, record management, internal information sharing, and regulatory compliance following a change in ownership or management.
    We also assist in prioritizing and addressing procedural and operational issues identified after the transaction or succession. Where appropriate, we coordinate with attorneys, judicial scriveners, tax accountants, labour and social security attorneys, regulatory specialists, and other professionals to support the development of a stable post-transaction operating structure.
  • Scope of Retainer Services
    The specific scope of a retainer agreement—including the frequency of consultations and meetings, the volume of document review or preparation, involvement in consultations with public authorities, and coordination with other professionals—is determined individually based on the nature of the business, the issues involved, and the client’s requirements.
    The extent to which license or permit applications, notifications, contract preparation, and other individual assignments are included in the monthly retainer will be agreed in advance. Separate fees may apply depending on the volume, complexity, or specialized nature of the work.
    Contentious negotiations or representation, matters reserved by law to other licensed professionals, and other services outside the professional scope of our office will be handled in coordination with an appropriately qualified professional where necessary.

Regarding Expenses (Actual Costs)

In addition to the professional fees above, the client is responsible for the following actual costs:

  • Application fees & Statutory fees paid to government agencies (Revenue stamps, Registration taxes, etc.)
  • Certificate acquisition costs (Certificates of Registered Matters, Tax payment certificates, etc.)
  • Postage and Transportation expenses: At cost
  • Research expenses (Purchase of literature, etc.): At cost (Consulted on a case-by-case basis)

If you would like a preliminary confirmation regarding whether your matter may be within our scope and the general fee range, please contact us via the inquiry form with a brief overview.