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 Office of Regulated Activities provides
consultation for regulatory, clinical, non-clinical, manufacturing, data management, and biostatistics support for FDA regulated drug, biologic, medical device, and combination products.
The Office of Regulated Activities organizational structure is intended to provide Integrated Product Teams (IPTs) and Project Management Offices (PMOs) specific regulatory branches and teams responsible for ensuring regulatory responsibilities are met on both TSG-DA Sponsored Products and Non-TSG-DA Products.
The Office of Regulated Activities (ORA) is organized into four branches with six integrated product/project teams 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. For more information click the Subject Matter Expertise icons below to learn more about the various capabilities housed in ORA :