Clear every headline, CTA, and disclaimer before the campaign ships.
Claim Clearance™ screens your campaign copy against the 21 CFR 1271 four-prong test, OPDP promotional standards, and FTC Section 5 deception rules. Paste 50 claims, get 50 verdicts, each cited to the CFR section and the enforcement action that set the precedent.
Same enforcement logic cited in MiMedx, Integra, Celularity, Chara, and Kimera warning letters.
- 01
"Our stem cell therapy regenerates damaged joints."
FailNon-homologous use + therapeutic effect. Implicates 21 CFR 1271.10(a)(2). Same failure pattern as US v. Cal. Stem Cell.
- 02
"FDA-registered facility" on a product page.
FlagRegistration ≠ approval. FTC Section 5 risk; OPDP will read this as misleading. Add disclaimer or strike.
- 03
"Exosomes for long COVID infusion therapy."
FailSystemic administration of unapproved biologic. Direct parallel to Restora Health warning letter (Mar 2024).
- 04
"Locally applied amniotic membrane allograft for chronic wound coverage."
PassHomologous use, local administration, no combination, no systemic effect. Stays within 361 pathway.
The agency workflow, rebuilt.
Claim Clearance sits inside your Q&A cycle. Copywriter drafts → you clear → client legal co-signs. No more Slack threads with vague "looks fine" verdicts.
Paste a CSV of 50 claims, an ad script, a landing page URL. We parse, split, and score each claim independently.
Separate workspaces for each client. Audit trail stays with the campaign. No cross-contamination.
Every verdict comes with the CFR citation and the enforcement action that sets the precedent. Your client's GC can sign it off in minutes.
When FDA guidance shifts (sepsis, TB, OPDP 2025), every prior campaign gets re-scored. You get an alert before your client does.
Flagged claims push to Slack or email instantly. Paste the verdict in your Google Doc, done.
Trigger a Claim Clearance check from your existing ops stack. Copy lands in Figma, clearance runs automatically.
Agency founding seats
First 25 agencies get Terminal + Claim Clearance free for 90 days.
In exchange, you give us 20 minutes of product feedback and one named testimonial when we launch publicly.