Articles tagged with “ai-regulatory-review”

FDA HALO & Elsa 4.0: Sponsor Guide to AI Submissions

Learn about the FDA's new HALO platform and Elsa 4.0 AI system. This guide covers consolidated eCTD submissions, AI review workflows, and sponsor migration.

35 min read

4/29/2026

fda halo platform elsa 4.0 regulatory submissions ectd consolidation ai regulatory review sponsor migration fda ai tools pharma compliance