ArcaScience

ArcaScience is a Paris-based AI healthtech company that has built the world's most comprehensive benefit-risk intelligence platform for pharmaceutical drug development and regulatory submissions. Its platform synthesizes over 100 billion biomedical data points using 24 AI models to automate benefit-risk assessments — reducing evaluation cycles from 12-18 months to near-instant analysis — and generates submission-ready regulatory documents including PSURs, RMPs, and CTD sections. Trusted by 20+ blue-chip pharmaceutical clients across 12 therapeutic areas, ArcaScience has supported 50+ regulatory submissions and is compliant with FDA 21 CFR Part 11, GDPR, and ISO 27001.