Regulatory Support
Bright's company-wide policy of hiring only seasoned staff with a minimum of six years' experience in clinical trials has made us the go-to CRO for crucial projects where time is tight and there's no room for the kinds of errors commonly made by more inexperienced staff.
Perhaps the area where this experience is most valuable is in dealing directly with FDA and IRB's. Our people have a long history of navigating the FDA regulatory process. Many members of our staff have been on both sides of the process, having worked within the FDA or having served on IRB's prior to joining our team.
Our regulatory staff and certified experts know the ins and outs of regulatory compliance and are savvy about the optimal ways to present the necessary data and reports to these agencies.
We'll help you maximize your effectiveness in the design of your protocols, and minimize delays in navigating the wide range of often conflicting regulatory requirements in dealing with the FDA, GCP, GMP, GLP, and CFR 21 Part 11.
Rather than simply entering the fray upon FDA or IRB submission, Bright's regulatory experts will be with you from the beginning, with site support and training to keep everyone on the same page. We will provide education and support for investigational new drug (IND) and new drug application (NDA) best practices, and of course, taking care of all necessary communications with the relevant regulatory agencies.
Bright will review your pre-clinical data and essential materials and site documents, evaluating them with an eye toward smooth FDA communications. We'll prepare documents prior to FDA meetings, and advise you every step of the way, keeping the wheels of progress running smoothly.
Documents we can help you effectively prepare and submit include:
- Investigational New Drug (IND) / Investigational Device Exemption (IDE)
- New Drug Application (NDA)
- 510(k) Clearance and Premarket Approval Process and Documentation
- Biologics License Application (BLA)
- Premarket Approval (PMA) / Product Development Protocol (PDP)