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Built by people who understand pharma.
AI-powered software for pharmacovigilance and drug sample transparency.
From adverse event to FDA submission in seconds. AI-powered pharmacovigilance — HIPAA compliant, 21 CFR Part 11 ready.
Learn moreFrom spreadsheet to FDA submission. Under two minutes. ACA Section 6004 drug sample transparency, simplified.
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Pharmacovigilance is the science of detecting, assessing, and preventing adverse effects of pharmaceutical products. AI-powered pharmacovigilance uses machine learning to automate the processing of adverse event reports — extracting medical terms, classifying severity, and generating regulatory submissions. Work that traditionally takes trained safety professionals hours per case can be completed in seconds.
Section 6004 of the Affordable Care Act requires drug manufacturers to report information about drug samples distributed to healthcare providers. This transparency provision helps the FDA track sample distribution patterns. Aura STP automates the data transformation and submission process required by this regulation.
Aura ingests adverse event reports from multiple sources, uses AI to extract and code medical terminology using MedDRA, identifies duplicate cases, assesses seriousness criteria, and generates submission-ready forms for the FDA's MedWatch and VAERS systems — reducing processing time from hours to seconds.
Yes. Aura is designed for HIPAA-regulated environments with appropriate administrative, physical, and technical safeguards. The platform is also designed to meet 21 CFR Part 11 requirements for electronic records and electronic signatures.
GalenLogic products serve pharmaceutical companies, biotech firms, and contract research organizations (CROs) that need to meet FDA regulatory requirements for pharmacovigilance and drug sample reporting.