OVERVIEW: OpenRegSource was developed by the SC CTSI 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. This web portal centralizes regulatory resources and tools from government, academic, and research institutions. Although it was designed to help academic researchers, in resource constrained environments, cut down the time it takes to search for regulatory information, it is accessible for everyone.
GOAL: To provide researchers with a free, easily accessible, self-help tool to obtain basic regulatory information prior to seeking professional and/or paid consultation.
CURRENT STATUS: 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.