About Truex Consultancy
Truex Consultancy is an independent GMP and GDP consultancy based in Amersfoort. We work with pharmaceutical, biotechnology and medical device companies across the Netherlands and the European Union.
The company was founded by Gregory Sivo after more than ten years working inside regulated quality environments. It exists to do one thing well. Solve compliance problems that are already causing damage and build the systems that stop them coming back.
10+ yearsin GMP and GDP environments
Netherlands and EUon site and remote
Direct accessto a senior specialist
Why we founded Truex Consultancy
After more than ten years inside GMP and GDP environments, one pattern becomes unmistakable. Standard off the shelf strategies rarely hold up when real world execution, tight timelines and rigorous compliance meet head on.
Consultancy was never meant to be about delivering heavy slide decks and leaving the hard work of implementation behind. It was meant to solve critical problems efficiently, give straight answers and protect your operations from unnecessary friction.
That is why Gregory Sivo founded Truex Consultancy. The purpose was to bridge the gap between high level strategic oversight and hands on implementation.
Built on three core principles
Uncompromising objectivity
Operating independently means our allegiance is solely to your outcomes. You receive candid, evidence based guidance unburdened by internal politics or corporate overhead.
Direct senior expertise
When you engage Truex Consultancy you work directly with an experienced specialist who understands the operational landscape from the inside. Not a junior team learning on your clock.
Pragmatic implementation
Regulatory frameworks and quality systems should not paralyse your business. We design and optimise processes that keep you compliant, lean and moving forward without administrative bloat.
Where our experience comes from
Our experience was earned inside the industry, not observed from outside it. We have worked with global contract manufacturing organisations, with Dutch generics and parallel import companies, and with pharmaceutical pre-wholesale distributors operating within international healthcare groups.
That range matters. Manufacturing, distribution and the Dutch regulatory environment each fail in their own way, and advice that works in one can be wrong in another. We have seen quality systems from the inside at every point in the supply chain, from batch release on a manufacturing site to the decisions a Responsible Person makes over returned stock.
We do not publish client names. Every engagement is covered by confidentiality, and that discipline applies to our former clients just as it would to you. References are available on request.
What that looks like in practice
The work might be remediating an operational bottleneck that has stalled release, streamlining a quality system that has grown too heavy for the people who have to use it, or establishing resilient systems from the ground up. The aim does not change. Targeted solutions built for immediate impact and long term durability.
In practice that means audits and gap assessments, interim quality cover, Responsible Person services under GDP, quality system builds and remediation, data integrity work, inspection preparation and support, and the strategic programmes that sit behind licence applications and site transfers.
Who we work with
Our clients are marketing authorisation holders, contract manufacturers, wholesale distributors, biotechnology companies moving from development into supply and medical device firms with a pharmaceutical component.
Company size matters less than the stage you are at. A company preparing for its first licence and a site recovering from a critical inspection finding need the same thing from us. A clear picture of where they stand and a plan that can actually be delivered with the people they have.
Where we are based
Truex Consultancy B.V. is registered in Amersfoort and works on site throughout the Netherlands and Belgium. We travel across the European Union for audits and inspection support. A significant part of the work is done remotely. The balance of on site and remote days is agreed before an engagement starts.
Work with us
If you have a problem that is already costing you time, tell us what happened. We will tell you honestly whether it is something we can help with.