HEMAVATHY MIDATHALA

AI is transforming pharmacovigilance by streamlining the creation of benefit-risk narratives—critical for regulatory submissions. It automates data extraction, detects safety patterns, ensures consistent language, and maintains compliance with evolving guidelines. Tesserblu enhances this process with AI-driven drafting, unified data integration, compliance checks, and explainable insights, enabling faster, more accurate, and regulator-ready reports that strengthen patient safety decisions.

Local language review is a critical yet time-consuming step in pharmacovigilance, often causing delays in ICSR submissions and regulatory compliance. Manual translations, time zone challenges, and inconsistent terminology increase risk and cost. TesserBlu streamlines this process with AI-driven translation, workflow automation, and compliance tracking, helping pharma companies accelerate submissions and ensure patient safety.

Accurate MedDRA and WHO-DD coding is vital in pharmacovigilance to ensure regulatory compliance, enable reliable signal detection, and maintain patient safety. Manual coding often leads to errors, delays, and inconsistencies. Leveraging intelligent automation with tools like Tesserblu helps streamline coding, ensure up-to-date dictionary use, and improve accuracy, enabling faster, audit-ready pharmacovigilance operations.