-3 months

・Understanding of Project

・GAP Analysis

・Creation of PMDA Consultation Meeting Strategy

・Conduct pre-Consultation Meeting (if need)

Meeting, Support of briefing book documentation, Documents review and so on (on-site support; 1 or 2 times/week）

-2 months

- 6 weeks

・Documentation of Briefing Book
・Conduct pre-Consultation Meeting (if need)

- 10 days to -2 days

・Inquiries and answers

・Receive of PMDA Opinion

・Internal Discussion of Counter proposal

・Creation and submission of comapny proposal
・Creation of presentation materials

On-site support

-1 day

・Creation of possible Q&A
・Internal Rehearsal

Consultation meeting

・Consultation Meeting facilitator
・Wrap-up meeting

+ 1 month

・Finalization of minutes

On-site support (if need)