Built to solve a problem no one else is solving
No company on Earth currently offers a GxP-validated AI system for real-time pharmaceutical batch monitoring. BatchCortex is changing that.
Vilmer Frost
Founder & Developer
I'm a 17-year-old developer based in Stockholm, Sweden.
I built BatchCortex after identifying a genuine market gap: pharmaceutical manufacturers lose €50,000–€5,000,000 per failed batch, yet no validated AI system exists to monitor and flag deviations in real time.
EU GMP Annex 22 is creating a regulatory tailwind for AI adoption in pharmaceutical manufacturing. BatchCortex is purpose-built for that moment — combining real-time process monitoring, multivariate anomaly detection, and GMP-compliant audit trails in one platform.
We're starting in the Nordic market and expanding across Europe.
The Problem
Billions lost annually
Batch failures cost the pharmaceutical industry billions every year. A single failed batch can mean €50K–€5M in lost materials, investigation costs, and delayed releases.
The Opportunity
Annex 22 mandates AI readiness
The EU's upcoming Annex 22 guidance creates regulatory requirements — and incentives — for AI adoption in GMP manufacturing. Early movers gain a compliance advantage.
Our Approach
Human-on-the-loop AI
BatchCortex keeps humans in control. AI analyzes and recommends; qualified personnel approve. Full audit trails, electronic signatures, and ALCOA+ compliance built in from day one.