Regulatory Affairs, a sub-unit within ORIA, serves as a resource to the Georgia Tech research community by offering regulatory guidance in all aspects of clinical research (GxP) from preclinical (GLP) requirements to first-in-human studies (GCP) and beyond (GMP). Our goal is to provide the Georgia Tech research community with the training and guidance needed to navigate the complex regulatory pathways that accompany FDA regulated research from conception through commercialization. This goal will simplify the challenges and maximize potential of a high quality output to get novel innovative products to market faster by helping to contribute to the promotion and protection of public health.
IMPORTANT NOTICE: The Food and Drug Administration (FDA) has released guidance on how clinical trials shall be conducted during the COVID-19 pandemic. Please CLICK HERE to read the guidance and see how this may impact your clinical trial.