Business

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.

step1	Identifying needs	Hearings
		Proposal for improvements
step2	Product concept planning	Market survey Intellectual property survey Regulatory survey Insurance-related survey Concept planning Business model preparation Planning/assessment
step3	Hypothesis verification/policy	Completion of the prototype Concept validation Feasibility validation
step4	Business plan	Intellectual property strategy planning Development strategy planning Clinical study plan Regulatory strategy planning Manufacturing process assessment Insurance strategy planning Sales strategy planning
step5	Medical Device application, health insurance reimbursement	Application strategy Health insurance strategy
		QMS・GVP
step6	National Health Insurance listing	Important index related to launching strategy
step7	Launching into the market	Overseas expansion Post-marketing safety control

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.