FDA Adverse Event Reporting Systems Consolidation

The FDA is seeking information from qualified small businesses regarding the consolidation of multiple adverse event reporting and product quality systems into a single enterprise-wide platform. The effort will modernize and expand pharmacovigilance capabilities using ArisGlobal’s LifeSphere MultiVigilance, AI-driven document processing, and AWS GovCloud hosting. This initiative will streamline reporting, improve regulatory compliance, and enhance data analytics across multiple FDA centers.