Full consultation service for PMDA-sponsor meetings
- Best speed: 5 months from 1st contact to PMDA minutes
- Lowest fully loaded costs
- Highest quality
We provide comprehensive services for successful PMDA consultation meeting. We will serve as a local contact for PMDA, help prepare Briefing Book and responses to PMDA inquiries, and conduct all translation in-house. Tasks include from the first contact with PMDA for a preliminary meeting through the finalization of meeting minutes. It usually takes 5-6 months for the entire process. For details, please refer to “Information Section” of this website.
Potential clients: Foreign biopharmaceutical companies without local Japanese staff / office, Japanese and foreign pharmaceutical companies short of regulatory affairs resources.
|1||Complete Package for a PMDA F2F consultation meeting from a preliminary meeting through the finalization of formal meeting minutes||$80,000|
|2||Preliminary consultation meeting only||$30,000|
|3||Formal consultation meeting only||$55,000|
|4||Other type of consultation (Please make an inquiry via an email)||Inquiry|
Note: The above service includes everything needed for successful interactions with PMDA including translation of Briefing Book, company responses and preparation of flash meeting minutes as well as expert advices. Costs not included are printing fee (About $1,500-2,000), simultaneous interpreter fee (About $3,000 for preliminary and formal meetings combined) and travelling expenses (about $1,000 per meeting). Actual costs will be invoiced.
Guide for a PMDA consultation meeting
|1||Complete Guide for Successful PMDA Consultation Meeting + All templates (PDF and WORD)||50||$999|
Analysis of Clinical Data Package
PMDA discloses “Review Report” for new drugs, which is on par with FDA’s Summary Basis of Approval.
We extract data from “Review Report” and reconstruct “Complete Clinical Data Package.”
Our analysis includes all studies submitted as “Evaluation Data”, sample size of each study (Japanese and non-Japanese), efficacy endpoint (both primary and secondary), comparator(s) and the PK strategy.
|1||Analysis of Clinical Data Package / drug||–||$999|
This information is critical when formulating the Japan Development Strategy. here