Academic researchers are challenged with navigating through regulatory hurdles, which often requires a great deal of time to search for information. In an effort to provide a solution, Professors Eunjoo Pacifici and Nancy Pire-Smerkanich envisioned creating a web portal that centralizes regulatory resources and tools from government, academic, and research institutions. The goal of this initiative is to provide researchers with a free, easily accessible, self-help tool to obtain basic regulatory information prior to seeking professional and/or paid consultation.

OpenRegSource was developed by SC CTSI’s Regulatory Knowledge and Support Core in collaboration with USC Mann D.K. Kim International Center for Regulatory Science and the USC Mann Department of Regulatory and Quality Sciences. The project team utilized an implementation science framework, diligently researching and procuring content. Additionally, improvements were made based on the feedback collected from a focus group conducted with participants made up of the clinical research workforce.

This initial launch of OpenRegSource includes resources for drugs, biologics, and medical devices through the following stages: patenting, manufacturing, clinical research, and regulatory paths to market. To access this tool, please visit https://sc-ctsi.org/resources/regulatory-resources.