The role also includes reviewing protocols, informed consent documents, and supporting materials; providing regulatory and operational guidance; supporting U-M institutional review boards, including review of applicable drug, biologic, and device submissions in eResearch; participating in consultations and educational activities; and developing regulatory tools, templates, procedures, and training resources. We support research involving investigational drugs, biologics, medical devices, and combination products from regulatory strategy development through study closeout, with a focus on the preparation and maintenance of Investigational New Drug (IND) applications and Investigational Device Exemption (IDE) applications.