Refua Regulatory

Build verifiable regulatory evidence bundles with end-to-end lineage across plans, tool calls, models, datasets, and generated artifacts. Designed for audit readiness and compliance workflows.

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E2E Lineage
SHA-256 Checksums
FDA Checklist Templates
JSON Structured Output

What Is Refua Regulatory?

Refua Regulatory helps teams follow drug regulation processes by turning campaign decisions and execution outputs into verifiable evidence bundles with end-to-end lineage across plans, tool calls, models, datasets, and generated artifacts.

Every decision in a Refua campaign is extracted, given a deterministic ID, and linked to its model provenance and data manifests. The result is a complete audit trail that supports internal regulatory readiness reviews before agency submission.

What It Provides

  • Campaign decision extraction with deterministic IDs
  • Model and data provenance capture per decision
  • Lineage graph materialization for traceability
  • Evidence bundle packaging with SHA-256 checksums
  • Integrity verification for audit handoff
  • Regulatory checklist evaluation with strict and manual-review gates

Evidence Bundle Contents

📄

Manifest

A structured manifest.json with bundle ID, creation timestamp, source campaign, and included artifact references.

📋

Decision Records

Structured decisions.jsonl with deterministic decision IDs, rationale, model/data provenance, and execution context.

🔗

Lineage Graph

A lineage.json connecting plans to tool calls to artifacts, enabling full traceability of every campaign output.

🔒

Integrity Checksums

SHA-256 checksums for every artifact in the bundle, enabling tamper-detection and verification for audit handoff.

✅

Regulatory Checklists

Automated checklist evaluation against drug discovery comprehensive and FDA/CDER AI-ML templates with strict and manual-review gates.

📦

Artifact Archive

Campaign run files, data manifests, and extra artifacts organized in a standardized directory structure for handoff.

Get Started

Installation

pip install refua-regulatory

Build an Evidence Bundle

refua-regulatory build \
  --campaign-run artifacts/kras_campaign_run.json \
  --output-dir artifacts/evidence/kras_run_001

Verify Bundle Integrity

refua-regulatory verify --bundle-dir artifacts/evidence/kras_run_001

Run a Regulatory Checklist

refua-regulatory checklist \
  --bundle-dir artifacts/evidence/kras_run_001 \
  --template fda_cder_ai_ml \
  --strict

Audit-Ready From Day One

Refua Regulatory ensures every campaign decision has a verifiable chain of evidence, making regulatory readiness a natural outcome of the discovery process.

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