The conversations already happening in your hallways
"Marketing asked ChatGPT to draft a leave-behind for the sales team. It pulled in an efficacy claim that isn't in our approved labeling. We caught it in MLR — this time."
Your marketing team is using AI to move faster. But ChatGPT doesn't know which claims are FDA-approved and which aren't. Every output is a compliance review from scratch.
"We spend three weeks in MLR review chasing down which claims came from approved labeling and which the AI just... generated."
Without source tracing, your regulatory team has to verify every claim manually — checking each statement against the PI, approved supplements, and fair balance language. MLR cycles that should take days take months.
"Veeva quoted us $200K for their content governance module. We're a 60-person biotech with one marketed product."
Enterprise compliance platforms assume a $2B pharma budget. For a mid-market biotech, that's not a solution — it's a line item that kills the initiative.
Let your team use AI. Control exactly what it sees.
Provenyx sits between the AI tools your marketing and medical affairs teams already use — Claude, ChatGPT, Gemini — and your FDA-approved content. It controls what each model can access, enforces your MLR policies, and keeps a full audit log of every interaction.
Every AI-generated output gets a provenance receipt: exactly which approved labeling and claims were referenced, when, by whom, and in which AI tool. That receipt is your MLR accelerator — and your FDA audit artifact.
- MLR guardrails per role: marketing vs. medical affairs vs. sales
- Provenance receipts linking every output to approved source material
- Setup in minutes — no IT team, no 12-month implementation
Three steps to MLR-ready AI governance
Provenyx isn't just another search tool; it's the intelligent infrastructure that organizes, secures, and feeds your private data to AI models safely.
Create approved content kits
Package your FDA-approved labeling, approved claims, fair balance language, PI references, and compliance guidelines into AI-accessible kits.
Set MLR rules per role
Your regulatory team defines which AI tools can access which content — with restrictions by role, content type, and intended use. Marketing sees approved claims. Sales sees leave-behind templates. Nobody sees raw clinical data.
Every output gets a receipt
When someone uses AI to draft promotional copy, Provenyx logs exactly which approved claims and labeling were referenced, when, by whom, and in which tool. That receipt accelerates MLR review.
What your team asks — and what stays off-limits
AI pulls only from the approved labeling supplement and fair balance language. The output traces directly to source material — so when it hits MLR review, your regulatory team verifies the receipt, not every individual claim.
- Fair Balance Language — Zeltria.docx
- Zeltria Approved Labeling Supplement v3.pdf
- Leave-Behind Template — Brand.pptx
- Phase III Raw Clinical Data.xlsx
Instead of manually matching every statement to its source document, your MLR reviewer pulls the provenance receipt. Each claim links directly to the specific section of approved labeling it was generated from. Review what matters, not what's already proven.
- AI Interaction Audit Log — March.csv
- Provenance Receipts — Sales Aid Q1.pdf
- Zeltria Approved Labeling Supplement v3.pdf
- Internal MLR Reviewer Notes.docx
AI accesses only the approved PI and clinical summary — not the promotional claims kit. The MSL gets a factual summary grounded in labeled data, with a provenance receipt showing no promotional material was used. Exactly what medical affairs needs.
- Zeltria PI — Rheumatology Indication.pdf
- Clinical Summary — Phase III Results.pdf
- Promotional Claims Kit — Zeltria.docx
