The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from the Southeast US 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, the Medical University of South Carolina, Virginia Commonwealth University, and University of Miami.
Combining the regulatory talents across these Institutions 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.
Meet the Duke ORAQ Regulatory Affairs team members
The goal of the South Carolina Clinical & Translational Research (SCTR) Institute Regulatory Knowledge and Support (RKS) program is to uphold the highest standards in human subjects protection by providing expert consultation, individualized training and mentoring to investigators, research professionals and trainees at MUSC. Our highly trained regulatory specialists work collaboratively with the community, local research offices, state-wide partners and across the CTSA consortium to provide education, develop policies, workflows, services and tools while utilizing a results-based accountability framework to evaluate program success.
Virginia Commonwealth University, through the Office of the Vice President for Research and Innovation and the C. Kenneth and Dianne Wright Center for Clinical and Translational Research, is invested in fostering transformative, collaborative, and translational research to enrich the human experience and advance human health and well-being. The VCU FDA Regulatory Resource Program provides guidance for VCU faculty-held IND or IDE research and supports institutional best practices for regulatory compliance and quality clinical research. Tailored training for sponsor-investigators and their teams comes from this program as well as from the Wright Center.
Established in 2012 and refunded in 2018, the Miami Clinical and Translational Science Institute (CTSI) drives research translation into evidence-based clinical and community practices that improve the health of South Florida's diverse population.
The Miami CTSI educates, trains, connects, and supports research teams by building the distinct science of clinical translational research, fostering collaboration, and managing the resources needed to sustain success in these areas.
The ReGARDD program is funded in part by Clinical and Translational Science Awards (CTSA) Program from the National Center for Advancing Translational Sciences, National Institutes of Health, to each of the member institutions:
The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.