Regulatory Strategy Development
Meeting Support / Facilitation with the Regulatory Authorities (PMDA)
- Gap Analysis for existing CMC, Pre-clinical & clinical data / reports
- Regulatory Strategy / Clinical Development Plan
- 2nd opinion on clients’ Regulatory Strategy
- Pre-meeting with PMDA
- Feedback from meeting with KOLs
PMDA offers face-to-face consultations to give guidance and advice on clinical trials of drugs and medical devices as well as on data for regulatory submission of Consultation for Safety (non-clinical), Quality (CMC), and Clinical Trial (e.g. before phase 1 trial, before / after phase 2 trial)
- General consulting services for PMDA meeting on clinical trials.
- Preparation of materials for Pre-PMDA meeting and the presence for Pre-PMDA meeting.
- Preparation of materials for PMDA meeting and the presence for PMDA meeting.
- Preparation of responses or support for the inquiry and the interpretations from PMDA
Clinical Trial Notification (this is part of our ICCC Service)
Orphan Drug Designation and Priority Review Application
Consultation for Post Marketing Surveillance
“Please feel free to consult us concerning without mention of other services as well.”
We provide our services based on accumulated knowledge and experiences in Quintiles, i.e. we use both global and local network to find best solutions for clients.
Consulting team consists of Japanese experts with wide range of Regulatory, CMC, Pre-clinical and Clinical experiences in both global and local drug development.