Regulatory Consulting Services | Oakton VA | Dunn Regulatory Associates

WE ARE THE TRUSTED EXPERTS

Our team of consultants brings decades of product development and regulatory consulting experience for pharmaceuticals, biologics and medical devices. We are dedicated to working closely with you through every stage of your product’s development process and help you bring your product to market in the most efficient manner.

WE CAN:

Develop pragmatic approaches to regulatory challenges
Negotiate with the FDA and EU
Write, manage and review all modules of the CTD, IB, annual reports, and meeting packages
Prepare Orphan Drug Applications
Develop concise and thorough regulatory strategies