Office of Regulatory Affairs and Quality provides regulatory guidance from preclinical requirements to first-in-human studies and beyond. The group serves as a no-cost resource to regulatory strategy development, IND/IDE preparation and maintenance, GCP/GLP/GMP requirements, and interfacing with regulatory authorities, such as the FDA. The regulatory affairs group also offers educational opportunities and internships. This office is part of the School of Medicine and is partially supported by the Duke CTSA grant.
For more information, contact Amanda Parrish, director of regulatory affairs and quality, at (919) 668-8772 or email@example.com.