QualityMind is the AI-powered QMS built for European biotech. Full EU GMP Annex 11 + FDA 21 CFR Part 11 compliance. Self-hosted AI — your data never leaves your infrastructure. From €5K/year.
The status quo is broken. Here's what we hear from teams like yours.
A €20M Series A shouldn't spend €100K/year on QMS — that's a senior scientist's salary. Every euro on systems is a euro not spent on your clinical program.
US-hosted QMS platforms put your data under the Cloud Act — not GDPR. Your SOPs, deviations, and audit trails are subject to US government access.
Most QMS platforms bolt on AI as a chatbot. None understand EU GMP and FDA simultaneously. None detect conflicts between jurisdictions.
Six integrated modules. One platform. Built specifically for clinical-stage European biotech.
Full lifecycle management. Draft, Review, Approve, Effective, Periodic Review. Version control with complete audit trails.
Assignments, quizzes, certificates, and curriculum tracking. Ensure every team member is qualified for their role.
Deviations, CAPAs, OOS/OOT investigations. Root cause analysis and trend detection with AI assistance.
AI pre-fills from uploaded documents. Built-in risk assessment. Track changes from initiation through closure.
Multi-jurisdiction analysis. EU GMP Annex 11, FDA 21 CFR Part 11, and ICH Q10. Cross-document contradiction detection with direct quotes.
21 CFR Part 11 compliant. Re-authentication with meaning declaration. Full audit trail for every signature.
Coming Soon
Write SOPs in Word, check in versions, and run AI compliance checks directly from the sidebar.
Microsoft Entra ID and Google Workspace. Enterprise-ready single sign-on with OAuth 2.0 / OIDC.
Not a chatbot. A compliance engine trained on regulatory frameworks that actually understands multi-jurisdiction requirements.
AI finds specific conflicts between your SOPs, policies, and work instructions — with direct quotes from both documents. No more manual traceability matrices.
Analyzes against EU GMP Annex 11, FDA 21 CFR Part 11, and ICH simultaneously. One document, three regulatory checks.
Automatically flags when EU requires X but FDA requires Y. No other QMS does this.
Upload a vendor notification or audit finding. AI extracts title, classification, risk, impact, and suggested actions automatically.
Mistral runs on our own EU GPU infrastructure. Your documents never leave your environment. No third-party API calls. Full data sovereignty by default.
One document checked against three regulatory frameworks simultaneously.
Select a document — SOP, policy, or work instruction
AI checks EU GMP, FDA, and ICH — scores each framework
Review by jurisdiction — accept, flag, or re-run
Upload a vendor release note or audit finding. AI reads it and pre-fills your change request.
Upload a document — vendor notification, CAPA, or regulatory change
AI pre-fills the form — title, risk, classification, impacted SOPs
You review and approve — AI assists, you decide
Every component of QualityMind is European-owned, European-hosted, and governed by European law.
Hosted on European-owned infrastructure in Swedish and Finnish datacenters. Governed by Swedish law. Not subject to the US Cloud Act.
Mistral models run on our own EU GPU infrastructure. Your documents are never sent to a third-party API. Full data sovereignty by default.
No US Cloud Act risk. Full GDPR compliance. NIS2 ready. All data stored under Swedish law on Swedish infrastructure.
Every competitor either hosts on AWS (US Cloud Act) or has no AI. QualityMind is the only QMS that is both sovereign and intelligent.
Transparent pricing. No per-document fees. No surprises.
Pre-clinical to Phase I
Less than one month of CRO fees
Phase I–III, scaling team
Less than a CMC consultant per quarter
Multi-site, on-prem needs
Custom pricing for your needs
The only platform that's simultaneously sovereign and AI-powered.
| QualityMind | Montrium Connect | SimplerQMS | Veeva Vault | |
|---|---|---|---|---|
| AI Compliance Engine | ✓ Multi-jurisdiction | ✗ None | ✗ None | ✗ None |
| Swedish / EU Hosting | ✓ Sweden + Finland | ✗ Canada / Azure | ⚠ EU (M-Files) | ✗ US (AWS) |
| AI Data Sovereignty | ✓ Self-hosted, no 3rd party | ✗ No AI | ✗ No AI | ✗ No AI |
| EU GMP Focus | ✓ Primary | ✓ Yes | ✓ Yes | ✓ Yes |
| Contradiction Detection | ✓ Cross-document + cross-jurisdiction | ✗ | ✗ | ✗ |
| Annual Cost | From €5K | €50–100K+ | €15K+ | €150K+ |
We spent years watching biotech companies burn €100K+ on quality systems — money that should have funded trials, hired scientists, or extended runway. The tools were bloated, the AI was US-hosted, and nobody built for small European teams. So we built what should have existed years ago.
We're onboarding a small group of design partners in 2026. Request early access and help shape the product.
Thanks for your interest. We'll reach out within 48 hours to discuss next steps.
