Pay Per Batch. Not Per Promise.
Per-batch pricing with a predictable annual floor. No seat licenses. No per-user fees. Your production volume drives your spend — and your CFO can forecast it.
€50K–€5M
Cost of one batch failure
< 2 batches
ROI breakeven point
200–500
Typical batches per site per year
MONITOR
min €24,000/year
+ €12,000 one-time setup
Real-time visibility into your batch process. Early warning before failures occur.
- OPC-UA & MQTT connectivity
- Real-time parameter monitoring
- Hard limit & drift detection
- Automated SMS/email escalation
- Immutable audit trail
- Annex 11 compliant dashboard
- Store-and-forward data buffer
- AI deviation report generation
- IQ/OQ validation support
- Electronic sign-off workflow
- LIMS at-line QC integration
- Material genealogy & recall trace
- NIR PAT ingestion + drift
ANALYZE
min €48,000/year
+ €18,000 one-time setup
Full anomaly detection with AI-generated GMP deviation reports and electronic sign-off.
- Everything in Monitor
- AI deviation report generation (<60 seconds)
- Electronic sign-off (21 CFR Part 11)
- Ghost Operator AI advisory
- Annual PQR generation
- Inspection Readiness Pack (unlimited)
- Scheduled monthly/quarterly pack generation (DST-aware)
- Batch comparison & heatmaps
- AI investigation chat
- QA feedback loop & model improvement
- LIMS at-line QC integration (CSV + adapter)
- Material genealogy & recall trace (API lot to batch)
- IQ/OQ validation document support
- EU-sovereign AI inference
- NIR PAT blend uniformity ingestion
- Annex 22 NIR input-drift monitoring
- Custom OPC-UA integration support
- Dedicated onboarding engineer
GUARD
min €78,000/year
+ €24,000 one-time setup
Full GMP compliance stack with dedicated onboarding, custom integration, and priority support.
- Everything in Analyze
- NIR PAT blend uniformity ingestion
- Annex 22 NIR input-drift monitoring
- Model registry & drift monitoring
- Training data pipeline & snapshots
- Custom OPC-UA/MQTT integration support
- Dedicated onboarding engineer on-site
- Custom alert thresholds & escalation rules
- Priority support (4-hour response)
- Quarterly compliance review calls
- Custom validation documentation
- Multi-line monitoring (unlimited lines)
What's Included in Setup?
Edge Deployment
We travel to your site and install the BatchCortex edge agent on your gateway hardware. OPC-UA or MQTT connection to your existing DCS/SCADA system. Your equipment is never modified — read-only connection only.
Validation & Legal
We walk your QA team through the IQ/OQ protocols and sign off on all required GMP validation documentation. Data Processing Agreement, Supplier Quality Assessment, and Change Control SOP included.
Handover & Training
Full walkthrough of the dashboard with your QA Manager and operators. Escalation configuration, alert threshold review, and 30 days of hypercare support after go-live.
Setup is a one-time fee per manufacturing site. Additional production lines on the same site can be added at reduced cost. Contact us to discuss multi-site pricing.
One Prevented Failure Pays for Years
€70,000
Analyze tier · 500 batches · annual recurring
€50,000–€5,000,000
Cost of a single prevented batch failure
< 2 batches
ROI breakeven point
Pharmaceutical batch failures cost between €50,000 for a straightforward rejection and €5,000,000 for a contamination event requiring full line shutdown and regulatory investigation.
BatchCortex detects anomalies 10–30 minutes before failure. In most cases, the batch is saved entirely — the cost is zero.
One or two prevented failures per year pays for BatchCortex for the rest of the decade.
First Pilot Partner Offer
We are actively onboarding our first Nordic pilot partners. Pilot partners receive 50% off the per-batch rate, the annual minimum, and the setup fee — in exchange for a brief written case study after 90 days. Limited to the first 3 partners we sign this quarter.
50%
Off every fee
90 days
Pilot period
Limited to 3 pilot partners. Currently 0 of 3 slots filled.
Apply for PilotCommon Questions
Everything you need to know about pricing, setup, and compliance.
Ready to Eliminate Batch Failures?
Join the waitlist. First pilot partners onboarding now — limited to 3 slots this quarter.
Join Waitlist