ARC Institution

ARCi - Your Medical Device Market Access Solution in Japan

Market Assessment

• ​Annual procedures
  
• Reimbursement landscape
  
• Estimated ASPs
  
• Competitors
  
• ​KOLs
  

Commercialization Execution

• ​Revisit agreed upon initial Market Entry Strategy as regulatory and reimbursement approvals draw near, validate initial assumptions are still valid, and that they continue optimize your launch, market penetration and access to patients
  
• Execute commercialization via agreed upon strategy; distributor, JV or direct model

Market Entry Execution

• ​Establish wholly owned legal entity subsidiary on your behalf
  
• Act as legal entity's Representative Director on your behalf
  
• Establish Marketing Authorization Holder (MAH) status on your behalf allowing for import license ownership at outset and ultimately direct import upon approval if so desired.
  
• Reimbursement optimization

Market Entry Strategy & Advisory

• ​Clinical requirements
  
• PMDA submission strategy
  
• Estimated regulatory timelines and time to market
  
• ​Alliance partner identification, M&A advisory, fundraising
  
• Distributer model​?

​​                    - Thorough due diligence to find the best fit for your therapy's distribution in Japan

• ​JV model?
  
• ​Direct sales model?