The Compliance Lifecycle
From raw evidence to regulatory filing — fully orchestrated.
Collect
Evidence Engine generates audit trails and compliance records
Review
Multi-stage review with role-based approvals
Assemble
Evidence Books compiled per project and per regime
Submit
Submission-ready packages for FDA, EMA, Health Canada
Key Capabilities
Multi-Stage Review Workflows
Define custom review stages for each compliance regime. Route evidence through subject matter experts, compliance officers, and executive approvers in the correct sequence.
Role-Based Approvals
Enforce separation of duties with configurable approval roles. Ensure the right people review the right evidence — with full electronic signature trails.
Submission Deadline Tracking
Track every regulatory deadline across FDA, EMA, Health Canada, and EU AI Act. Automated alerts when evidence gaps threaten submission timelines.
Cross-Team Coordination
Break down silos between R&D, Quality, Regulatory Affairs, and Legal. Shared dashboards, task assignments, and progress tracking for the entire compliance lifecycle.
Evidence Collection Orchestration
Automatically collect evidence from the Evidence Engine, trigger review cycles, and assemble final Evidence Books — end-to-end orchestration from raw data to regulatory filing.
Part of The BioCompute AI Foundation