Fair balance & risk presentation
Every risk claim is checked for prominence, readability, and consistency with the PI. The fair-balance report flags any imbalance between efficacy and risk presentation.
The most rigorous promotional clearance package a brand team can submit.
The Enforcement-Risk Clearance Engine assembles a submission-ready, pre-cleared package — every claim substantiated, every fair-balance element checked, every risk flag mapped to live OPDP enforcement letters — reviewed by a licensed regulatory specialist before release.
Every subsection of 21 CFR 202.1 & Part 801Claim-substantiation matrix, gate-checkedOPDP enforcement-letter corpus (200+ letters, 2025)Licensed reviewer sign-off on every pack24-48 hour SLA
Why packs fail
A single unsubstantiated claim can trigger an OPDP letter.
Every promotional asset must clear MLR before use, and MLR is the acknowledged bottleneck — 50-60 days per piece in the US vs ~20 in the EU, with siloed feedback and manual rework. In 2025 the cost of getting it wrong spiked: FDA sent 200+ enforcement letters, many hitting DTC risk presentation.
Small/mid brands and agencies feel this hardest: they lack a full PRC, can't absorb six-figure enterprise platforms, and face launch dates that slip every time review stalls. The pain is simultaneously speed (missed launch windows), cost (expensive reviewers/agencies), and risk (public enforcement).
The Enforcement-Risk Clearance Engine exists to close that gap with a single, exhaustive standard applied identically to every file.
200+
OPDP enforcement letters in 2025, up from ~5 in 2024
The benchmark
Measured against the letter of the regulation — subsection by subsection.
We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 21 CFR 202.1, Part 801, and FDCA 502(n). These are the provisions each pack is held to.
Claim substantiation
Every efficacy or safety claim is linked to a specific reference (label, clinical study, or published literature). Unsubstantiated claims are flagged with the supporting evidence gap.
Brief summary / adequate provision
For DTC print ads, the brief summary is verified for completeness. For broadcast, the adequate provision (major statement) is checked against the PI.
Labeling consistency
All promotional claims are cross-referenced against the approved PI/label. Any deviation in indication, dosing, or safety language is flagged.
Enforcement-risk mapping
Each claim is compared against the live corpus of OPDP Untitled and Warning Letters (200+ from 2025). Similar language or presentation patterns are flagged with the relevant letter citation.
Form 2253 readiness
The package includes a completed Form 2253 draft, with all required fields populated and the asset attached, ready for submission within 5 business days of approval.
How a pack is built
Intake to specialist release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A human specialist signs every release. That order is never reversed.
01
Risk Gap Scan
Upload the asset and PI. We return a free completeness read: which regulatory elements and substantiation you already have, and which are missing.
02
Evidence & reference ingestion
As your authorized clerical agent, we ingest the PI, clinical references, and any prior OPDP letters. We build a claim-reference matrix corroborated across sources.
03
Grounded drafting
The claim-substantiation matrix, fair-balance report, and risk flags are drafted from your validated data and the regulatory rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
Every claim is linked to a reference; fair-balance metrics are computed; the OPDP corpus is searched for similar language; Form 2253 fields are populated. Any failure blocks release.
05
Specialist release
A licensed regulatory reviewer verifies the off-label/medical/risk chokepoints and signs the release. High-risk or novel claims route to attorney review first.
06
Delivery
You receive the pack: annotated asset, claim-substantiation matrix, fair-balance report, risk-flag report with OPDP citations, suggested redlines, and a Form 2253-ready dossier — ready for internal MLR submission.
The bar we hold
Rigor you can measure.
100%
Specialist-released
No pack ships without a licensed reviewer signature.
24-48 hrs
Standard SLA
From complete intake to released pack.
<1%
Critical-defect target
Tracked against a gold-standard pack library.
200+
OPDP letters in corpus
Every enforcement precedent mapped to claim language.
Why this engine
Built to be the most thorough option a brand team has.
Submission-ready, by design
The deliverable is a pre-cleared package — every regulatory element and substantiation accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run searches as your clerical agent. We never provide legal advice, approve the asset, or submit to FDA on your behalf.
Engagement
Flat fee, per released pack. No retainer, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any revenue.
- A free Risk Gap Scan before you commit — see exactly what is missing.
- One flat fee per released Clearance Package; disclosed pass-through reference fees.
- Optional fixed-fee attorney review for high-risk or novel claims.
- Optional Campaign Continuity Add-on for multi-asset campaigns, pre-priced per asset.
FAQ
Questions, answered precisely.
Is this a law firm?
No. The Enforcement-Risk Clearance Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for high-risk or novel claims.
Do you submit to FDA or approve the asset?
Never. We prepare the documentation package for your internal MLR review. Your brand team and legal/medical reviewers retain full approval authority. We do not submit Form 2253 on your behalf.
What makes a pack 'complete'?
Completeness is defined by the regulations: every claim substantiated, fair balance verified, risk flags mapped to OPDP precedents, and Form 2253 fields populated. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is 24-48 hours from complete intake to a specialist-released pack. The free Risk Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through reference costs. No retainer and no percentage of any revenue.
See what's missing before it triggers an OPDP letter.
Start with a free Risk Gap Scan. Send your asset and PI and we'll return a completeness read against every subsection of 21 CFR 202.1 and the OPDP enforcement corpus.
Documentation-completeness service · not legal advice · your team retains full approval authority.