RegulaVita's AI-Augmented Pharmacovigilance Management platform transforms drug safety operations by automating the entire PV workflow—delivering faster, better results using fewer resources.

Traditional PV processes involve manual literature searches, lengthy email chains, and inconsistent formatting—taking an average of 8.3 hours per case. Our AI solution automates two critical workflows: PV Case Intake (digitalization and structuring of incoming cases) and PV Response Generation (deep research over trusted sources like SMPCs, PubMed, and EMBASE to draft bespoke responses). With human-in-the-loop validation steps and advanced reasoning AI, cases are processed in just 5 minutes with 100% regulatory compliance. This represents a 99% reduction in processing time and 90%+ cost savings, while ensuring full adherence to ICH E2B(R3), FDA 21 CFR Part 314.80, and EMA EudraVigilance standards.