GMP sites are deploying AI. Regulators are arriving to inspect it. We're building the infrastructure that captures every interaction, validates it against your governance policy, and produces the audit trail your quality team needs.
"Show me what the AI did, what data it touched,
and what human oversight occurred_"
Most sites today cannot answer this question.
FDA Inspector · GMP Manufacturing Floor
Quality teams are caught between two pressures: pressure to adopt AI tools for efficiency, and regulatory pressure to document every decision those tools make. Right now, there is no infrastructure that bridges them.
LLMs and AI-assisted platforms are already in use on GMP sites — often without formal IT governance. Quality teams are adopting tools their QMS was not designed to track.
EU GMP Annex 22 — the first AI-specific pharmaceutical regulation — is in consultation now. FDA issued draft guidance in 2025. The window to implement governance proactively, rather than reactively after a finding, is closing.
QMS vendors validate processes — not AI interactions. Security tools flag data leaks — not GxP taxonomy violations. Consultancies write SOPs — not audit trails. No tool currently produces inspection-ready AI documentation.
The Window
Sites that implement AI governance ahead of the mandate walk into inspections with evidence. Sites that wait respond to findings. The difference is not the technology — it's the timing.
AI in regulatory decision-making. First formal signal from the FDA.
Enters consultation. First AI-specific pharma regulation globally.
Quality directors implement ahead of mandate. The window is open.
Non-compliant sites face inspection findings. The window closes.
US AI governance mandated. Full global enforcement begins.
Three steps, one inspection-ready output. This is the framework we're building — designed to work regardless of which AI tools your site uses, and regardless of how they are accessed.
The system is designed to capture every AI interaction at full fidelity — through a controlled interface for low-footprint sites, or a gateway layer for full-stack coverage. The goal: nothing missed, regardless of how AI is being accessed on site.
Each captured interaction will be classified against a GxP life-sciences taxonomy, checked against your site's governance policy, and flagged for data sovereignty issues — before the interaction completes.
The output is a single inspection report — regardless of which AI tool generated the interaction or how it was accessed. One SOP. One validation document. One training record. Designed to hold up in front of an inspector.
Both tiers are designed to produce the same inspection output. Deployment approach scales with your site's IT complexity and existing AI tool footprint.
A controlled interface for LLM access. Minimal deployment. Built to get sites capturing quickly.
A gateway layer for sites with a broader AI footprint. Designed to cover every tool, on-premise.
We're building the documentation layer your QMS was never designed to provide — so you can present a complete AI activity record to any inspector, for any tool, from a single report.
Implementing governance proactively positions your site ahead of the mandate — not in remediation after a finding. We're designing DuxBio's output to align with Annex 22 requirements as they are currently drafted.
DuxBio Lite is designed to get sites capturing quickly — with minimal IT involvement. Your quality team gets the audit trail they need. Your operations team keeps the tools they're already using.
"Do you have a documented process for AI use? Can you show me every AI-assisted decision made in the last 12 months, who authorised it, and what data it used?"
DuxBio was founded by people who have worked inside pharma GMP environments and understand the regulatory pressures quality teams face — not as consultants observing from the outside, but as practitioners who lived them.
We combine deep GxP domain knowledge with AI and software expertise. We are not a technology company that discovered pharma — we are pharma people who identified the gap no software company had closed, and are building the infrastructure to close it.
Quality directors should own AI governance, not wait for IT to deliver a solution. We're building DuxBio to be adopted by quality teams directly — with as little IT friction as possible.
Compliance shouldn't depend on users remembering to document their AI interactions. We're building DuxBio to capture at the infrastructure level — so the trail is generated, not manually filed.
Sites use multiple AI tools. Inspectors ask one question. DuxBio is designed to produce one answer — a unified interaction record aligned to GxP standards, regardless of vendor.
We're working with a small number of quality teams in 2026 to develop and validate the product. If you're dealing with this problem now, we'd rather have that conversation than send you a brochure.
We're working with a select group of quality teams ahead of Annex 22 finalisation. No sales process — just a conversation about your site's AI footprint and whether DuxBio is the right fit.
No sales pitch. We'll reply within one business day.