Japan Market Entry for Life Science Tech, MedTech & Diagnostics.

We provide a strategic blueprint for innovators in Life Science Tech (AI Platforms, SaaS), MedTech(Medical Devices, SaMD), and Diagnostics (IVD, Reagents) seeking to navigate Japan's complex regulatory and market landscape.

Entering Japan: A huge opportunity, a unique set of challenges

For innovators in Life Science Tech, MedTech, and Diagnostics, Japan is a critical market. But the path to success is unclear.

  • Are you facing Japan's unique PMDA / MHLW regulatory hurdles for your medical device, SaMD, or diagnostic product (IVD)?
  • Are you struggling to find the right distribution partners or enterprise clients for your specialized technology?
  • Do you need to validate if Japanese pharma and academia will adopt your AI platform or SaaS product?
  • You need a partner who understands your specific vertical and the local Japanese ecosystem.

Specialized Expertise. Proven Results.

  • Our Expertise Covers:
    • Life Science Tech (AI Drug Discovery, Bioinformatics SaaS, R&D Platforms)
    • MedTech (Medical Devices, Software as a Medical Device - SaMD)
    • Diagnostics (In-Vitro Diagnostics - IVD, Reagents)

Your Blueprint for a Successful Japan Market Entry.

Our Japan Market Entry Assessment is your essential first step. It is a productized consulting service designed to give you maximum strategic value for a fixed price.

FeatureBasic AssessmentFull Assessment
ScopeMarket & Go-to-Market StrategyMarket Strategy + Applicable Regulations Research*
Price$3,000 USD$7,000 USD
DeliveryApprox. 4 WeeksApprox. 6-8 Weeks
Payment Terms100% Upfront50% Upfront / 50% on Completion
Best forClients in early stages, focused on market viability and strategic direction.Clients who need a strategic market plan, supported by a foundational list of relevant regulatory documents.
Regulatory CheckpointsOut of Scope✔ (Key Component)
Deliverable SampleDownload Basic Sample (PDF)Download Full Sample (PDF)

*Disclaimer: The Applicable Regulations Research provides a list of publicly available information for reference and does not constitute legal or regulatory advice. The interpretation and completeness of this information should be verified with a qualified professional.

From Blueprint to Market Success: Your Full-Service Partner.

The "Japan Market Entry Assessment" is your essential first step. Once your strategic blueprint is complete, we provide hands-on, long-term support to turn your plan into reality. Our ongoing partnership services include:

  • Partner Identification & Alliance Building
  • Business Development & Market Penetration
  • Business Model & Pricing Strategy
  • Localization & Market Readiness

These ongoing support services are tailored to your specific needs and are structured as a monthly retainer or project-based fee, discussed after the completion of your initial Assessment.

A Proven Process for Clarity and Confidence.

1. Discovery & Kickoff: We start with our questionnaire, followed by a kickoff meeting to align on the "definition of success."

Go to Questionnaire:

2. Analysis & Mid-point Check-in: We conduct our deep-dive analysis and hold a check-in meeting to share early findings and confirm our direction.

3. Delivery & Strategy Session: We deliver the final report and schedule a presentation to walk you through the key findings and answer all your questions.

More Than a Consultant. Your Partner in Japan.

Probio is not a large, faceless consulting firm. We are your personal bridge to Japan.

Ready to build your bridge to the Japanese market?

Schedule a complimentary 30-minute call to discuss your goals and see if our service is the right fit for you.

Please note: To ensure the highest quality of service, we accept a limited number of new Assessment projects per quarter.

Have more questions? Read our Frequently Asked Questions (FAQs).

Oversea Partners

South Korea

A digital health solution that uses AI-powered smartwatches to automatically monitor and record medication intake in real time, enhancing patient engagement and supporting decentralized clinical trials (DCTs).

  • Automatic detection and recording of medication intake via camera-equipped smartwatch
  • Improved medication adherence and data collection efficiency in DCT settings
  • Reminders and real-time interventions to encourage ongoing adherence
  • Detection of various medication/measurement behaviors, including injections, inhalers, and blood glucose testing
  • Health data visualization and remote support through mobile app and web integration

Belgium

A cloud-based Medical Backend-as-a-Service (BaaS) platform with built-in data encryption and regulatory compliance, enabling rapid development of SaMD and remote patient monitoring applications.

  • Rapid backend setup for SaMD and connected medical device applications
  • End-to-end encrypted infrastructure supporting compliance with GDPR, HIPAA, HDS, DiGA, ISO 27001, and more
  • Support for remote patient monitoring and DCT application development
  • Advanced healthcare solution development with AI, machine learning, and data analytics
  • Accelerated prototyping, regulatory approvals, and global deployment

France

Developer and manufacturer of natural and organic-certified cosmetics and personal care products, utilizing thermal spring water from southern France.

  • Development and manufacturing of natural formulas with Cosmébio and Ecocert organic certification
  • Oral and skin care products made with Castéra-Verduzan thermal spring water
  • Custom manufacturing of a wide range of formulations, including gels, foams, sprays, powders, soaps, and aerosols
  • Cleanroom manufacturing with strict microbiological and physicochemical quality control
  • 100% in-house production in Gers, France, with an environmentally responsible, ethical approach