Enter & Expand in Japan’s Healthcare Market
We help healthcare companies enter, build, and scale in Japan—faster and with less risk.
From regulatory strategy to distribution and local partnerships, we don’t just advise—we execute.
We work with medical device, diagnostics, pharmaceutical, and consumer health companies.
Our focus is simple: turn opportunities into real business.
What We Do
Partnering, Licensing and Business Development
We help healthcare companies enter Japan and Asia by securing the right partners and closing real commercial deals.
What we deliver
- Partner Identification & Qualification
Find and validate distributors, strategic partners, and key stakeholders - Licensing & Deal Structuring
Build commercially viable licensing and partnership models - Negotiation & Deal Closure
Lead discussions and bring deals to execution - Commercialization Support
Align product, pricing, and channels for successful market entry - Post-Deal Partner Management
Ensure long-term performance and growth with local partners
We focus on outcomes — not introductions, but signed agreements and active business.
Regulatory Strategy & Market Access (Japan)
We help healthcare companies navigate Japan’s regulatory landscape and bring products to market efficiently and compliantly.
What we deliver
- Regulatory Strategy & Pathway Design
Define the fastest and most appropriate route for approval - PMDA & MHLW Engagement
Prepare and lead consultations with regulatory authorities - Product Registration Support
End-to-end support for approval and notification processes - Reimbursement Strategy
Align regulatory and pricing pathways for commercial success - Quality & Compliance (QMS / GVP)
Ensure systems meet Japanese regulatory requirements - Post-Market & Clinical Support
PMS, vigilance, and clinical development coordination
Our goal: reduce delays, avoid costly mistakes, and accelerate your market entry in Japan.
Japan Market Entry & Representation Models
Local Representation (Japan)
We act as your local presence and execution partner in Japan — enabling you to operate, build relationships, and grow your business without establishing your own entity.
What we deliver
- Local Market Presence
Represent your company in Japan with a professional and trusted footprint - Partner & Customer Management
Manage relationships with distributors, partners, and key stakeholders - Business Development Execution
Support sales activities, lead generation, and market expansion - Industry Engagement
Coordinate participation in trade shows, conferences, and professional networks
Operational Support
- Communication handling under your company name
- Coordination with local partners and stakeholders
- Access to meeting space and on-ground support
- Regular reporting and business updates
Interim Management (Healthcare)
We provide experienced executives and operators to lead critical functions, manage transitions, and accelerate execution in Japan and Asia.
When clients engage us
- Entering or expanding in Japan without a local leadership team
- Managing transitions, restructuring, or urgent business challenges
- Building or stabilizing commercial, regulatory, or operational functions
- Requiring experienced leadership without long-term hiring commitments
What we deliver
- Hands-on leadership across commercial, regulatory, and operations
- Rapid deployment of experienced healthcare professionals
- Execution-focused management to drive measurable outcomes
- Knowledge transfer to internal teams for long-term sustainability
Our network
We maintain a strong network of healthcare industry executives and specialists ready to engage on an interim basis — enabling fast, flexible, and high-impact support.
Ideal for companies that need immediate execution without the delay of permanent hiring.
DMAH (Designated MAH) & Market Access in Japan
We act as your Designated Marketing Authorization Holder (DMAH) — enabling you to enter and operate in Japan without establishing your own local entity.
What we deliver
- DMAH Representation
Act as your licensed representative in Japan for medical devices and IVDs - Regulatory Execution
Manage registration, approvals, and compliance with PMDA and MHLW - Quality & Compliance (QMS / GVP)
Ensure ongoing regulatory and post-market compliance - Distributor Search & Management
Identify, negotiate, and manage local distribution partners - Commercialization Support
Bridge regulatory approval with real market access and sales execution
Why BIC Partners
- Licensed First-Class MAH (all device classes)
- Capable of handling end-to-end regulatory + commercial execution
- Unique ability to combine DMAH + business development + distribution support
“The BIC GROUP has allowed our small US-based company to accelerate our growth in Japan while shielding us from the headaches of Local Representation Services.”
“BIC group supported us in regulatory questions and in the strategy development for our presence in Japan. The consultants were specialists with many years of practical experience in Japan providing us with concrete answers to our practical and strategic answers.”
“We have been very impressed by BIC’s work for us in finding optimal partners in their region for marketing and sales of our products, and subsequently help us manage and empower these partners for optimal performance in the market.”
Development and Maintenance of Regulatory Intelligence database
“We were contacted by BIC Group just in time when we were verifying our go to market concept for Japan. It has been difficult for us to find the right distribution partner as the language barrier for western companies is still very high. The managing partner of BIC Group that we worked was acting very professional. He has been working in that specific industry for many years. Based on the scope of our business he recommend three large distribution companies to us and established contact to the right person in the organization. After personal meetings with all three companies we have chosen the one that fits best to our needs.”