Regulatory Affairs

Our Regulatory Affairs group supports PIs and their study teams in all aspects of clinical research. Our goal is to provide the University of Miami community with the tools, training, and support needed to navigate the complex regulatory pathways that accompany clinical research. Our regulatory group will be responsible for communicating with the FDA by submitting INDs and supporting documents, submission of annual reports, safety reports, and any updates within a clinical trial while also serving as the primary liaison for FDA communications.

Our services include identifying, gathering, and organizing essential documents needed for the initiation of a clinical research study. In addition to communicating with the IRB by supporting the study team and submitting documents needed for IRB approval, continuing to review reports, deviations, and or any reportable events, while serving as a liaison for the IRB of record. Lastly, our regulatory team will maintain and collect all electronic trial master files for the sponsor and all sites involved in a clinical research study. Our regulatory team will ensure compliance-oriented efficient, organized, and quality services.