Office of Regulated Activities
- The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs and clinical compliance professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, and biostatistics support for FDA regulated drug, biologic, medical device, and combination products.
- Levels of Support
- Full support for The Surgeon General-Department of the Army sponsored products and research efforts
- Oversight for all TSG-DA sponsored products contracted out to Contract Research Organizations
- Oversight for contracted product development for non-TSG sponsored products
- Consultation/Advisory Services for non-TSG-DA sponsored activities
- The ORA is organized into a Regulatory Business Support Office and seven integrated Branches that provide consistent, competent and timely management and oversight for FDA-Regulated products. Regulatory support begins with the initial regulatory strategy and throughout advanced development, to mitigate risk and accelerate the delivery of FDA-Regulated products to Service Members.
Last Modified Date: 16-Nov-2019