Building the intelligence layer for regulated manufacturing

Qualigon is built for environments where every decision must be traceable, defensible, and reviewable. Instead of treating regulation as a constraint, we made it the foundation of the system — shaping how data is structured, how analysis is performed, and how outputs are generated.
We believe teams operating in these environments should have access to modern, high-leverage tools — without compromising on rigor or control.

Founders

Over a decade of life sciences & engineering experience.

Jelle Demeulenaere

Co-founder & CEO

5 years of experience in the medical device and CDMO industry. Holds master's degrees in Chemical Engineering and Business Economics.

Dane Limjoco

Co-founder & CTO

Experience across multiple pharma and GMP environments, including assay development, vaccines, and cancer research. Studied Bioengineering at Cornell University.

The problem

The same bottleneck,
at every site.

Most of the time goes to data gathering, not thinking

Pull historian logs, request the batch record, find the applicable SOPs, cross-reference LIMS, check maintenance history. By the time the data is assembled, half a day is gone — before anyone has written a sentence of analysis.

“I have to dig through procedures, technical docs, specs — I’ll literally make notes on paper just to get started. Then during the analysis part of the investigation, a significant factor is pulling all the data from different systems and putting it together in a compliant format.”
— Deviation Investigator, US CDMO (CHO biomanufacturing)

Teams want to use AI, but generic solutions aren't built for this

Investigators are reaching for AI to help with writing and structuring their work — but generic tools aren't grounded in regulations or site-specific knowledge, and most companies prohibit putting process data into external models at all. The appetite is there. A safe, compliant path isn't.

“I’ve used ChatGPT to help with writing and organizing my thoughts. But the answers aren’t grounded in the regulations we need to apply to our written reports, so I don’t really trust them. And for data analysis, that would be a game changer, but I can't use it, the company does not allow us to put any of our data into it.”
— QA Manager, Novo Nordisk

A slower investigation is a batch that sits on hold

Investigation timelines directly impact batch releases. Three weeks to close a deviation is three weeks a batch doesn't move. Faster, more defensible investigations are how critical products reach patients sooner.

“We’ve had issues with one of our CMOs being slow to release batches because investigations weren’t getting resolved. It got to the point where I sent them our template because we really needed that batch — but I can’t fill it in for them.”
— Process Engineer, Amgen

What we're building

AI that speeds up investigations — from data gathering to final report.

If you work in quality at a pharma or CDMO site and want to talk through what you are dealing with, we would like to hear it.

hello@qualigon.co →