Regulatory & Compliance

Built for regulators, not retrofitted for them.

Core message

Built for regulators, not retrofitted for them.
Compliance as an output, not a constraint.

Designed to align with regulatory expectations and evidence workflows.

Regulator-ready evidence packages with traceable metadata.

Structured metadata to support consistent submissions.

Aligned data governance, auditability, and nonclinical safety expectations.

SEND-ready metadata built from standardized, ontology-driven structures.

Traceable evidence packages that reduce review friction.

Provenance and change history to support compliance reviews.

Access controls, retention, and validation for regulator-grade stewardship.

Structured metadata supports new approach methodologies without losing regulatory traceability.

Metadata reuse and comparability enable virtual control group workflows.