Medical & Pharma AI Compliance Gate — Pass MLR, Evidence, COI & AI-Use Checks Before Your Content Ships
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.
- Pre-check an AI-assisted publication or abstract before MLR or journal submission.
- Catch fabricated or misrepresented citations in AI-drafted medical content.
- Verify AI-use disclosure, COI, and GPP authorship practice are in place.
$14
· or 70 creditsSecure checkout via Stripe
Included in download
- Pre-check an AI-assisted publication or abstract before MLR or journal submission.
- Catch fabricated or misrepresented citations in AI-drafted medical content.
- Ready for Works with Claude Code
Sample input
"Check this AI-drafted congress abstract before it goes to MLR."
Sample output
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.
Medical & Pharma AI Compliance Gate — Pass MLR, Evidence, COI & AI-Use Checks Before Your Content Ships
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.
$14
· or 70 creditsSecure checkout via Stripe
Also available in a bundle
Included in download
- Pre-check an AI-assisted publication or abstract before MLR or journal submission.
- Catch fabricated or misrepresented citations in AI-drafted medical content.
- Ready for Works with Claude Code
- Instant install
Sample input
"Check this AI-drafted congress abstract before it goes to MLR."
Sample output
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.
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.
Use Cases
- Pre-check an AI-assisted publication or abstract before MLR or journal submission.
- Catch fabricated or misrepresented citations in AI-drafted medical content.
- Verify AI-use disclosure, COI, and GPP authorship practice are in place.
- Flag off-label claims or missing safety information before formal review.
Known Limitations
A readiness pre-check only — not legal, regulatory, or medical advice, and not a substitute for MLR, qualified medical/regulatory review, or human accountability. It can't independently verify a citation's content without access to the source, so it flags what to verify. Codes and SOPs vary by region and company and change; defer to them.
How to Install
mkdir -p ~/.claude/skills && curl -sL https://www.agensi.io/api/install/medical-pharma-ai-compliance-gate-pass-mlr-evidence-coi-ai-use-checks-before-your-content-ships -o /tmp/medical-pharma-ai-compliance-gate-pass-mlr-evidence-coi-ai-use-checks-before-your-content-ships.zip && unzip -o /tmp/medical-pharma-ai-compliance-gate-pass-mlr-evidence-coi-ai-use-checks-before-your-content-ships.zip -d ~/.claude/skills && rm /tmp/medical-pharma-ai-compliance-gate-pass-mlr-evidence-coi-ai-use-checks-before-your-content-ships.zipFree skills install directly. Paid skills require purchase - use the download button above after buying.
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Permissions
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Works with Claude Code, Cursor, Codex CLI, Gemini CLI, and other SKILL.md-compatible agents. For medical/scientific content: publications, abstracts, slide decks, med info, and promotional/non-promotional materials.
Creator
PubsProToolkit builds adversarial "gate" skills for AI agents — they catch problems before your output ships, instead of just generating more. From code, security, and infrastructure to content, hiring, contracts, and finance. Built by a CMPP-certified, PhD medical writer who brings regulated-industry rigor to every domain.
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