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Verify every AI output before it reaches the regulator

AI agents are fast, confident, and wrong often enough to matter. Meerkat catches fabricated adverse event rates, misquoted trial data, and inaccurate label claims before they reach an FDA submission or a pharmacovigilance report.

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AI agents are fast, confident, and
wrong often enough to matter

Statistically significant
AI described a secondary endpoint as the primary outcome. The number was correct. The context made it misleading.
Layer 1 saw matching data. Layer 2 caught the misattribution.
Well-tolerated
AI concluded the drug was well-tolerated by omitting two of six adverse events above the reporting threshold.
What the AI left out was more dangerous than what it included.
FDA Complete Response
A single mischaracterized endpoint in a submission summary can trigger a Complete Response Letter and delay launch by 12-18 months.
The cost of subtle errors in regulatory documents

Two gates between the AI
and the submission

Ingress Gate
Shield scans inputs to regulatory AI workflows
  • Catches manipulation attempts in submission preparation
  • Prevents injection attacks in safety reporting workflows
  • Sanitizes inputs to label review systems
Egress Gate
Verify checks every output against trial data
  • Adverse event rates checked against CSR tables
  • Efficacy endpoints verified against study reports
  • Dosing information confirmed against protocol
  • Safety signals cross-referenced with source datasets

The errors that delay approvals

Endpoint Misattribution

The AI reported the primary endpoint result using data from a secondary endpoint. The number was real, pulled from the correct table, but assigned to the wrong outcome measure. Layer 1 sees matching data. Layer 2 understands which endpoint is which.

Omitted Safety Signals

The AI summarized four adverse events. The CSR lists six above the 5% threshold. The two missing events had the highest severity ratings. The summary was technically accurate about what it included and dangerously incomplete about what it left out.

Subgroup Conflation

Efficacy reported for the full intention-to-treat population, but the number came from the per-protocol subgroup. Higher efficacy, smaller denominator, different clinical meaning. The AI merged two populations without noting the distinction.

Mischaracterized Significance

The AI described a result as clinically meaningful when the trial only demonstrated statistical significance. A p-value of 0.04 with a minimal clinically important difference that was not met. The qualifier changes the regulatory interpretation entirely.

Dosing Frequency Error

Recommended dosing stated as once daily when the approved label specifies twice daily. The milligram amount was correct. The total daily exposure was half of what was studied in the pivotal trial.

The audit trail your compliance
team has been asking for

Every AI interaction is logged, scored, and traceable. Not a monthly report. Continuous, automated oversight.

Complete Audit Trail

Every verification produces a signed record: what was checked, what passed, what was flagged, how it was resolved. Exportable for regulatory review.

Agent Identity

Every AI agent in your environment is registered, authenticated, and monitored. Full lifecycle governance for every AI agent.

Heartbeat Monitoring

Real-time status of every AI agent. If an agent goes silent, drifts from its baseline, or behaves anomalously, you know immediately.

FDA and EMA Submission Ready

Audit trails structured for regulatory inspection. Complete provenance for every AI-generated summary, analysis, and safety report in the eCTD package.

Automated Compliance Reporting

Dashboard showing verification rates, flag rates, resolution times, and trust score trends across your entire AI fleet. No manual log pulling.

ISO 42001 Alignment

Meerkat's continuous monitoring maps to emerging AI management system standards, providing the infrastructure between Big Four audits.

Your trial data never
leaves your environment

Cloud API

Pre-anonymized trial data. Zero retention. 5 minutes.

Hybrid Sidecar

Runs inside your regulatory affairs infrastructure. Patient-level data stays internal.

Self-Hosted

Air-gapped. For pre-submission review and confidential clinical data.

Start verifying pharmaceutical AI output today

Free tier. 10,000 verifications/month. No credit card.