Regulatory Clinical Trial Support

PRA's Regulatory Affairs team has effective liaison experience with multinational regulatory authorities and is skilled in the coordination and preparation of large multinational regulatory submissions. Regulatory Affairs work closely with clients and PRA's Project Startup services group to accommodate complex trials and deliver effective integrated planning and implementation for Phase I-IV clinical trials. Our regulatory services ensure a thorough quality control review of each submission is performed for verification of compliance with applicable guidelines. In addition, PRA's Regulatory Affairs team performs the ongoing maintenance of applications.

PRA has extensive experience in clinical trial management, as listed below:

Regulatory support to global clinical trials – Phase I through Phase IV
Project Startup consultation
Preparation and coordination of Clinical Trial Applications, INDs
Comprehensive client support for Regulatory Authority interactions
Clinical trial Labeling review and support
Import License Applications
Maintenance of applications
End of study activities