Dunn Regulatory Associates, LLC Employee Directory
Pharmaceutical ManufacturingVirginia, United States11-50 Employees
Dunn Regulatory Associates, LLC is a small- to mid-sized regulatory affairs firm located in Oakton, Virginia. It specializes in regulatory strategy, US Agent services, and regulatory document preparation to support the development of Rx and OTC pharmaceuticals, biopharmaceuticals, devices, and cosmetics. The firm emphasizes integrating strategic, scientific, and regulatory perspectives to help streamline development efforts. Its clients are product developers seeking guidance on regulatory pathways, IND maintenance, and the preparation of submissions across key documents such as CTD modules and the Investigator’s Brochure. The firm also handles negotiations with U.S. and European authorities and supports expedited regulatory routes, including Breakthrough Therapy, as well as the preparation of integrated development plans.