RegulaVita

Traditional PV Process

Manual, time-consuming, and inefficient

PV Request
Remote PV TeamManual processing
PubMed
EMBASE
Response
8.3 hours

⚠️ Bottlenecks: Manual search, email delays, human error

RegulaVita's AI transforms pharmacovigilance processing by automating the entire workflow. Traditional PV processes involve manual literature searches, lengthy email chains, and inconsistent formatting—taking an average of 8.3 hours per request. Our AI solution directly ingests PV requests, conducts instant literature research across validated medical databases, and generates structured, regulatory-compliant responses in just 5 minutes. This represents a 99% reduction in processing time while ensuring full adherence to ICH E2B(R3), FDA 21 CFR Part 314.80, and EMA EudraVigilance standards.