Challenges to entering the Japanese market
-
How complex are the regulatory
requirements? -
How will we build the right execution
framework? -
What level of investment will
be required? -
Which Japanese partners should we
collaborate with?
PATH-Solution
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One unified platform supporting you from entry strategy to post-launch
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Comprehensive market research, regulatory strategy, and premium distribution planning
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Flexible, tailored entry models designed for each company
How PATH-Solution supports overseas companies
Market Entry Assessment to Approval
Market Analysis
Market Entry Feasibility Evaluation Support
- Marketability assessment
- NHI Drug price/HTA simulations
- ROI trial calculation
- Partner selection
- Total cost clarification
Development
Regulatory and Development Support
- PMDA initial consultation/approval pathway design
- Key opinion leader (KOL) collaboration/advisory board formation/clinical trial and CMC requirement selection/application form preparation support
- Clinical trial preparation
Post-Marketing Distribution
Manufacture
System Design and Manufacturing Support
- GQP / GVP operational design
- Manufacturer and distributor selection
- Providing manufacturing capabilities for investigational drugs and commercial products
Sales and
Distribution
Distribution
Distribution Support
- Sales and distribution network creation
- Achieving a stable supply by utilizing a GDP‑compliant quality management system and a nationwide distribution network
- Supporting the optimization of production planning
Post-Marketing Surveillance
Post‑Marketing Surveillance Support
- Good Post Marketing Surveillance Practice
- Safety information management/annual reporting/data integrity (DI) compliance /patient care/ registry study/database analysis/outcome evaluation
The Alfresa Group and Its Alliance Partners
Enter Japan with clarity.
Execute with confidence
CONTACT
Contact us by email