Contextual safety reporting,
from strategy to submission
Unify periodic and aggregate reporting across every
regulatory obligation on one AI-native engine.
Reporting workflows, fully orchestrated
Plan, co-author, validate, and submit every safety report end to end, on one operating model.
Strategy & planning
Track every report against product, jurisdiction, regulatory obligation, and due date.
One reporting dataset
Connect case data, literature, and signals into one verified, version-controlled dataset.
Contextual intelligence
Build every report from the full history and safety context of the product.
Multi-agent drafting
Purpose-built agents draft each section’s narrative from the evidence.
Collaborative authoring
Sections route automatically to the right expert for review, refinement, and approval.
Document management
Keep every report version, template, and approval in one place.
Continuous validation
Check data quality and integrity as every report is built, across past reports too.
Submission and filing
AS2/ESTRI transmission, eCTD packaging, and immutable version snapshots.
Ad hoc reporting
Build ad hoc reports on demand, beyond the scheduled cycle.
PBRER · PSUR · DSUR · PADER · RMP/REMS · Ad hoc
Every regulatory jurisdiction — global & regional
One workflow,

continuously connected
Every reporting activity in one contextual workflow, so teams can see what is ready, what requires attention, and what comes next.
AI accelerates the report.
Experts own the judgment.
Automation absorbs volume, speed, and
consistency while safety experts focus on scientific
interpretation, risk, and decisions.
AI handles volume and consistency, in hours
Experts review with judgment and context
Reporting becomes
continuous,
not cyclical
Instead of reconstructing context for every report, connected safety intelligence carries over from one reporting obligation to the next.
What contextual reporting delivers
Efficiency
Months to
weeks
Compliance
100% on
day zero
Unified platform
From strategy
to submission
Accuracy
End-to-end
provenance
Fits the environment
you already run
The AI-native reporting engine plugs into your existing systems, Graph Safety or not. Across every product, obligation, jurisdiction and cycle.
Regulatory confidence at every step
The questions regulators ask of a report,
answered as the report is built.
Audit

traceability
Every sentence traced to source, with a full audit trail to filing.
21 CFR Part 11 compliant
Decision
explainability
Benefit-risk conclusions follow defined, documented reasoning.
Inspection-ready
Expert

accountability
Sections route automatically to the right expert for review and approval.
Role-based verification
Compliance
alignment
ICH E2C(R2), GVP Module VII and regional rulesets.
Continuously validated
Bring contextual intelligence
to every report
Move from periodic reporting cycles to a
connected safety operation.