The Office of Regulatory Affairs and Quality (ORAQ) serves as a no-cost resource to the academic research community at Duke University Medical Center. Our mission is to provide the academic research community with the tools, training, and support needed to navigate the complex regulatory pathways that accompany translational research. Our Office offers regulatory and quality assurance support in all aspects of translational research, including early regulatory strategy development; preclinical testing and product manufacturing; regulatory submissions and maintenance; and FDA meetings and inspections. For more information on our services and to meet our staff, please visit the webpages below.
Leadership and Administration
Under the direction of Amanda Parrish, PhD, RAC, the Office of Regulatory Affairs and Quality provides guidance and support to Duke Investigators manufacturing, developing, or conducting research with FDA regulated products. This includes investigational drugs, biologics, medical devices, and tobacco products. The leadership team is responsible for providing strategic input on FDA regulations pertaining to product manufacturing, product development, and clinical trials research. In conjunction with regulatory and quality staff, the leadership team advises on early regulatory strategy development, preclinical testing, Good Manufacturing Practice (GMP) regulations, and FDA meetings and inspections. The leadership team is supported by administrative professional staff and oversees the development and implementation of educational, operational, and collaborative programs hosted by the office.
Regulatory Affairs Team
The regulatory affairs team is responsible for supporting Duke investigators who are developing or conducting research with investigational medical products. The team is comprised of regulatory affairs professionals that have extensive scientific training. Under the direction of leadership, the regulatory affairs team provides guidance to investigators and study teams involved in clinical research and for which FDA oversight is required. This support includes early regulatory strategy development, regulatory application submission and maintenance, requests for meetings with FDA, as well as regulatory education and training. The regulatory affairs team is supported by document specialist staff and is involved in the implementation of educational, operational, and collaborative initiatives hosted by the office.
Quality Assurance Team
The quality assurance team is responsible for quality oversight of investigational product manufacturing at Duke University. The team provides dedicated support to Good Manufacturing Practice (GMP) facilities across campus, including the Robertson Clinical and Translational Cell Therapy Program (CT2), the Carolinas Cord Blood Bank (CCBB), the Duke Human Vaccine Institute CGMP Program (DGP), and the Molecular Products and Cellular Therapy (MPACT) Manufacturing Facility. The quality assurance team provides customized support for review of quality documents and agreements, internal and external audits, and general consultations on quality-related matters. The quality assurance team is supported by document specialist staff.