Engineering consultancy · Regulated manufacturing
We design, qualify and de-risk industrial control and monitoring systems for GMP manufacturing, from requirements to a fully validated, data-integrity-compliant handover. Less rework. Faster qualification. Audits you walk into with confidence.
What we do
Deep expertise where automation engineering meets the quality system, so the technology and the documentation arrive validated together, not as an afterthought.
Design and integration of industrial control systems for Grade A–D environments, from instrumentation and PLC/SCADA logic to a robust, maintainable architecture.
End-to-end CSV under GAMP 5, risk-based and lean. Protocols and evidence that hold up to inspection without drowning the project in paper.
Next-generation particle and environmental monitoring (EMS/BMS) designed for the revised Annex 1, continuous monitoring, alarming and a defensible data trail.
Make data integrity structural, not procedural. Audit trails, access control and records that are Attributable, Legible, Contemporaneous, Original and Accurate by design.
Keep systems inspection-ready through their life. We author, assess and close changes and deviations so quality and engineering stay in lock-step.
Purpose-built AI/LLM tooling that automates documentation, data triage and recurring engineering tasks, strictly within GMP data-integrity constraints.
How we work
One engineering thread that carries the technical solution and the compliance evidence together, the reason projects finish without a validation scramble at the end.
Map the process, the regulatory exposure and the real shop-floor constraints. Risk drives where effort goes.
Architecture and specifications written so qualification is straightforward, traceable and lean from day one.
IQ/OQ/PQ executed with clean, contemporaneous evidence and ALCOA+ integrity throughout.
Inspection-ready documentation, plus change control and CAPA discipline that keeps it that way.
Why work with us
Most projects lose time at the seam between engineering and quality. We live on that seam. A PhD-grade engineering mindset, fluent in GMP, turns shop-floor problems into validated, automated solutions, and writes the evidence to prove it.
Start a conversationWhere we work
“The validation evidence was ready when the system was, not three months later. That is how every qualification should feel.”
The earlier compliance is engineered in, the cheaper and faster the whole project runs. Let's scope it before the validation crunch finds you.
Contact details to be added.