IBM Consulting Agentic Application – Regulate-AI

IBM Consulting and AWS are transforming how regulated industries manage submission authoring with Regulate-AI, an enterprise-ready agentic AI solution that automates and optimizes regulatory documentation processes. Built for life sciences, pharmaceuticals, and other compliance-intensive sectors, Regulate-AI streamlines the creation of structured submissions such as Common Technical Documents (CTDs) by replacing fragmented, manual tasks with collaborative AI agents. These intelligent agents simulate specialized roles—such as Writer, Reviewer, and Regulator—and operate with machine-to-machine communication to deliver faster, more consistent results than traditional single-agent systems. The platform supports multimodal inputs, connects with Microsoft Word and Veeva Vault, and maintains audit-ready traceability through human-in-the-loop oversight. It is optimized for integration with AWS-native services and enterprise ecosystems, ensuring interoperability, governance, and scale.

What you get: Clients engaging with Regulate-AI receive a focused consulting and prototyping experience designed to: • Assess current-state regulatory authoring workflows and identify inefficiencies • Define high-impact automation use cases for agentic AI • Recommend secure integrations with document systems and compliance platforms • Embed AI governance, traceability, and human oversight into every step • Demonstrate measurable acceleration in time-to-submission and reduction in manual effort

With Regulate-AI, organizations gain a scalable foundation for regulatory operations that improves quality, reduces risk, and transforms authoring speed from months to weeks.