The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from North Carolina Institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel Hill, Duke University, Wake Forest School of Medicine, and RTI International.
Combining the regulatory talents from the North Carolina CTSAs and the research triangle park (RTP) area enables sharing of ideas, lessons learned, historical information, and the development of successful strategies to assist the academic researcher in navigating an increasingly complex regulatory environment. To learn more about each of the affiliates involved in ReGARDD, click on the institution's logo below:
The North Carolina Translational and Clinical Sciences (NC TraCS) Institute Regulatory Affairs Office provides regulatory support, guidance and education to the research community of UNC and its affiliates. Our aim is to lessen the regulatory barriers to translational research, by providing comprehensive support for researchers as they navigate the varying stages of investigational drug, medical device and biological product development and research. Some of our services include early consultations with the FDA, protocol review and evaluation, submissions of INDs/IDEs, DSMB support of phase 2 and 3 clinical trials, as well as assisting with long term maintenance and reporting requirements of clinical trials. The goal of our service is to advance science and discovery at UNC, while providing knowledge and empowerment for our academic investigators.
The IND/IDE Navigator in the Clinical and Translational Science Institute (CTSI) was established to provide regulatory support, guidance, and education services to faculty investigators involved in US Food and Drug Administration (FDA) regulated clinical research at Wake Forest School of Medicine.
Our primary focus is regulatory assistance to clinical sponsor-investigators planning to utilize either a drug or biological product classified by the FDA as an Investigational New Drug (IND) per 21 CFR Part 312 or a medical device subject to Investigational Device Exemption (IDE) regulations per 21 CFR Part 812. Our efforts help ensure clinical research excellence and regulatory compliance as set forth by Wake Forest School of Medicine and the FDA.
RTI international's highly experienced team can provide project management and biomedical product development expertise to plan and coordinate your preclinical and clinical projects. Our team understands drug development and regulatory approval process with pharmaceutical industry expertise in toxicology, pharmacology, clinical research, chemistry, manufacturing, and controls (CMC) and regulatory affairs.
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.