Regulatory Copilot for Pharma & Biotech is a SaaS platform that combines submission drafting, eCTD/RPS validation, regulatory intelligence, and audit-ready trails to keep teams inspection-ready across drugs, biologics, and devices. It unifies complex regulatory workflows into a single, scalable solution designed for life sciences teams seeking faster, more compliant submissions.
Key features include:
Regulatory Copilot helps life sciences teams reduce submission cycle times, improve compliance quality, and stay inspection-ready across drug, biologic, and device programs through a single integrated platform. By combining drafting, validation, intelligence, and auditable processes in one place, it minimizes risk, accelerates time-to-market, and supports ongoing regulatory readiness throughout development, filing, and post-approval life cycles.