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U.S. Army Medical Materiel Development Activity

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 USAMMDA 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 Business Support Office and eight 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. For more information click the links to left to request regulatory support or Sponsor protocol review.


Office of Regulated Activities (ORA)

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Office of Regulated Activities (ORA)


 

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Last Modified Date: 12/19/2017