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Medical & Pharma AI Compliance Gate
Audit AI-assisted medical and pharma content for compliance-readiness before it enters formal MLR review or journal submission. It checks claim substantiation and on-label scope, reference integrity (the acute AI risk: fabricated or misrepresented citations), fair balance and safety, AI-use disclosure, ICMJE authorship and GPP, COI and funding, data integrity and patient privacy, and adverse-event flags — then returns a PASS / REVISE / BLOCK verdict with the must-fix list. A readiness pre-check built for the regulated reality of medical communications — not a replacement for formal review.
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See it in action
You say
"Check this AI-drafted congress abstract before it goes to MLR."
Your agent does
A BLOCK verdict: the "significantly outperformed" wording exceeds what a single-arm result supports (soften to the data); two citations verify but the third can't be confirmed and may be fabricated (verify against the primary source before use); AI assistance and medical-writing support aren't disclosed (add per GPP/ICMJE). A prioritized must-fix list, ending "BLOCK until the citation is verified and the claim is on-label" — with the reminder that this is a pre-check, not formal MLR sign-off.
What you get
About this skill
This catches the issues that get medical content rejected at MLR or by a journal — before it goes to formal review — so AI-assisted drafts don't bounce or ship something unsupportable.
It is a readiness pre-check (not a replacement for formal MLR, qualified medical/regulatory review, or human accountability) and it defers to your applicable codes and SOPs (FDA/OPDP, ABPI, EMA, IFPMA, ICMJE, GPP 2022).
It checks:
- Claim substantiation & on-label scope — nothing stronger than its evidence, nothing off-label
- Reference integrity — the acute AI risk: fabricated citations, or real ones that don't actually support the claim (verified or flagged for primary-source check, never passed blind)
- Fair balance & safety information
- AI-use disclosure & human accountability (AI is never an author)
- ICMJE authorship & GPP 2022 publication practice — no ghost/guest authorship, writing support disclosed
- COI & funding disclosure
- Data integrity & patient privacy (no fabricated data, no PHI)
- Adverse-event flags routed to pharmacovigilance
- Permissions and promotional-vs-non-promotional classification
You get a PASS / REVISE / BLOCK verdict with the must-fix list — what a reviewer would catch, caught early.
How to install
Drop the file into your AI Agent. Works with Claude, Cursor, ChatGPT, and 20+ more.
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Creator
PubsProToolkit builds rigor-first skills for AI agents — they write your docs and content properly, then adversarially review them to catch what's wrong before it ships. The result: cleaner output and a hard quality gate in one toolkit. Built by a CMPP-certified, PhD medical writer who brings regulated-industry standards to developer docs, content, compliance, and research integrity.
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