Business flow

Conscientious consulting service will see you through the entire process

First, inform us as to what you need and what you find difficult. By listening carefully to your needs, we will provide you with precisely the information and know-how required.

step1Identifying needs
  • Hearings
  Proposal for improvements
step2Product concept planning
  • Market survey
  • Intellectual property survey
  • Regulatory survey
  • Insurance-related survey
  • Concept planning
  • Business model preparation
  • Planning/assessment
step3Hypothesis verification/policy
  • Completion of the prototype
  • Concept validation
  • Feasibility validation
step4Business plan
  • Intellectual property strategy planning
  • Development strategy planning
  • Clinical study plan
  • Regulatory strategy planning
  • Manufacturing process assessment
  • Insurance strategy planning
  • Sales strategy planning
step5Medical Device application, health insurance reimbursement
  • Application strategy
  • Health insurance strategy
step6National Health Insurance listing
  • Important index related to launching strategy
step7Launching into the market
  • Overseas expansion
  • Post-marketing safety control
  • QMS: Quality Management System
  • GVP: Good Vigilance Practice

Ongoing suggestions are made to facilitate advancement to the next phase of business in Japan:

The client is asked to select a person to be in charge, who will be given advice to ensure that the client acquires know-how on regulatory affairs as "their own property," rather than just providing information on regulatory pharmaceutical affairs minimally required for market entry.

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