For pharma MLR & promotional review teams

Catch the violation before it’s an FDA letter. Hyfstele catches 96%.

It reads every promotional claim against the full OPDP enforcement record, flags the risks a trained reviewer would, and leaves a signed record that survives an audit. Your reviewer makes the final call. The record defends it.

MLR is live today. The same defensible engine extends to manufacturing, aerospace & defense logistics.

Measured, not asserted

0 %

of real violations caught on a 100-letter test.

Catch rate
96%
Recall on a 100-item held-out OPDP set. A human still makes the final call.
Accuracy
= Opus
Met or beat Claude Opus 4.8 head-to-head on the same letters — on an owned model.
Provenance
Signed
Every verdict recorded in a tamper-evident cair-v1 chain — classical + post-quantum.

Catch rate = recall on known violations across a 100-item held-out OPDP set (95% CI 90–98%). Exact-category accuracy 71%; the reviewer refines the precise label. Internal benchmark, June 2026.

The problem

Every claim you ship is one missed risk from an FDA letter.

01

The queue only grows.

More pieces, more claims, more channels, faster launches. The review queue never shrinks — and the enforcement record it’s checked against keeps getting longer.

02

A copilot can’t be trusted here.

It hallucinates citations, can’t ground in the OPDP record, and leaves no trace of why it said what it said. So a reviewer re-checks everything anyway.

03

So review stays the bottleneck.

You can’t lean on AI for the routine until its calls can be proven right. And the one claim that slips through becomes the letter.

The review gate

It does the routine. You judge the exceptions.

01
Flag

Every claim read against the full OPDP precedent archive. The risks a trained reviewer would catch, surfaced with the letter they track.

02
Decide

Your reviewer accepts, rejects, or rewrites — on the routine 60–70%, the call is already made. Judgment goes where judgment is required.

03
Prove

Every decision and its basis sealed into a signed record that holds up when someone asks “who cleared this, and on what?”

The record

A signed chain that defends every call.

Each analysis and each decision is hashed, signed, and anchored to a tamper-evident ledger. Years later, an auditor verifies it without re-contacting us.

FIPS 180-4 · SHA-256 Ed25519 + ML-DSA-65 cair-v1 event chain 7-yr WORM
Why Hyfstele

What a reviewer can’t. What a copilot won’t.

vs. a reviewer alone

Reads the whole record

No reviewer holds the entire OPDP enforcement history in their head. Hyfstele checks every claim against all of it, and catches 96% of real violations.

vs. a general copilot

Grounded and signed

ChatGPT and Claude hallucinate citations and leave no trace. Every Hyfstele flag cites the real letter it tracks, and every verdict is sealed into a tamper-evident record.

vs. a black-box vendor

You own the model

Your claims and your data never leave the building. On a model you own, Hyfstele matched Claude Opus head-to-head on the same 100 letters.

See it catch a real issue.

Patent-pending PSI — US Prov. 64/069,537 SPRS 109/110 · CMMC L2-ready FIPS 180-4 signed records · 7-yr WORM