for regulatory affairs
Submissions an inspector can verify.
Every synthesis ships with a signed reproducibility package — manifest, source list, prompt hashes, SHA-256 signature. Built so the methodology block in your dossier is defensible, not just plausible.
The regulatory bar for AI-assisted evidence work
- FDA, EMA, MHRA, and Health Canada now expect documentation of how AI-assisted outputs were produced. 'We used an LLM' isn't a methods statement.
- Retraction-aware citation checking isn't an audit-grade nice-to-have anymore. Citing a retracted paper in a submission is a credibility-destroying error.
- Generic AI tools store user data on third-party infrastructure. For regulatory work that's often a non-starter regardless of accuracy.
- Reproducibility — can a reviewer rerun your analysis and get the same answer? — is the new bar. Most tools can't show how they got their answer.
What Embarke gives a regulatory team
Reproducibility ZIP for every report
Drop the signed package into your regulatory binder. Contains: full Markdown/DOCX/PDF export, manifest.json (model IDs, prompt SHA-256, framework + output format, generation timestamp), full source list with tiers + retraction flags, BibTeX + RIS exports, and a SIGNATURE file. A reviewer can detect any tampering after issue.
Methodology stamp at the top of every export
Quoted-callout block: framework name, output format, total cited sources, retracted-paper count, prompt fingerprint. Provenance is the first thing the reviewer sees, not buried in an appendix.
Retraction-aware citations end-to-end
Crossref + Retraction Watch enrichment on every DOI; retracted or expression-of-concern papers earn inline badges, a top-of-report banner, and a critical Critic issue that blocks Writer approval. A retracted paper does not slip into a submission unnoticed.
Self-host option for data sovereignty
Embarke runs on Talos K8s; the open-source stack supports your own deployment on your own Kubernetes. Your evidence work, your data, your audit log. No third-party AI vendor with access to your submission drafts.
What a regulatory-grade submission looks like
Generate a PRISMA 2020 systematic review on your clinical question → export the reproducibility ZIP → include the ZIP in your submission's methodology appendix → reference the manifest's prompt hash in your methods section. The signed package gives reviewers a deterministic record of what produced the document. The Critic's reporting-standard checks (CONSORT/STROBE/STARD/TRIPOD+AI/PRISMA) ensure each cited study's design is correctly handled in the synthesis.
See an example submission
Free tier — three syntheses, no credit card. BYOK for the LLM so your costs stay on your account.