Who We Are


Duke University

The Duke Office of Regulatory Affairs and Quality (ORAQ) team serves as a no-cost resource to the clinical research community at Duke University Medical Center. We offer regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to investigational drug/biologic manufacturing to IND/IDE submissions in support of first-in-human studies and beyond. All of our team members have a strong scientific background, in addition to regulatory expertise, which allows for us to serve as a liaison between clinical investigators and the U.S. Food and Drug Administration (FDA). Our goal is to provide the Duke community with the tools, training and support needed to navigate the complex regulatory pathways that accompany translational research.

Office of Regulatory Affairs and Quality
ORAQ@duke.edu
http://medschool.duke.edu/oraq

Who We Are