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:

• Submission drafting and eCTD/RPS validation: Auto-generates submission chapters from trial data and regulatory inputs, enforces eCTD structure, and flags non-compliance early to speed up approvals.
• Regulatory intelligence and guidance tracking: Aggregates global regulations, guidance documents, and agency expectations; provides alerts and templates aligned to jurisdiction-specific requirements.
• Audit-ready trails and version control: Immutable change logs, timestamped approvals, and exportable dossiers that simplify inspections and post-submission audits.
• Collaborative review workflows: Role-based permissions, comments, and automated notifications to keep writers, reviewers, QA, and management synchronized while reducing back-and-forth.

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.