We partner with:

• Pharmaceutical companies
• Biotechnology companies
• Rare disease drug developers
• Specialty pharma companies
• Clinical development companies

Japan offers significant opportunities — but entering the market before approval can be complex.

Many global companies face challenges such as:

• Navigating Japan’s strict regulatory framework (PMD Act)
• Lack of a reliable local partner
• Difficulty supplying unapproved medicines
• Limited access to hospitals and physicians
• Complex importation and logistics requirements

Bio Pharmacy provides a complete solution for delivering unapproved medicines to patients in Japan.

We support:

• Early Access Program (EAP)
• Named Patient Program (NPP)
• Compassionate Use / Expanded Access
• Managed Access Program (MAP)

From regulatory compliance to delivery — we handle everything.

• Extensive experience in pharmaceutical importation and supply
• Deep expertise in Japan’s regulatory environment (PMD Act)
• Established network with hospitals and medical institutions
• GDP-compliant logistics and temperature-controlled distribution
• Fast, flexible, and reliable execution

We manage the entire process in Japan — so you don’t need a local entity.

• Importation support (documentation & regulatory procedures)
• Named patient supply
• Coordination with medical institutions
• GDP-compliant pharmaceutical distribution
• End-to-end logistics management

Japan is one of the largest pharmaceutical markets in the world, with strong demand for innovative therapies.

Significant unmet medical needs remain in:

• Rare diseases
• Oncology
• Neurology
• Biologics
• Gene therapy

Many treatments approved in the US and Europe are not yet available in Japan, creating a critical opportunity for early access.

• No local entity required
• Full regulatory support provided
• Compliant and secure supply chain
• Support for urgent patient needs

We help bring life-changing treatments to patients in Japan — safely and efficiently.