Advisers who have had to defend the answer
GMP Consultant works with life-science manufacturers in the Netherlands to close the gap between compliant on paper and compliant in practice. That is the gap inspectors are trained to find and that quality teams rarely have the time to look for themselves.
How we work
We rank, we do not list
A gap register with 140 undifferentiated items is a way of transferring the hard judgement back to you. Every finding we raise carries an exposure rating and a recommended position in the queue, including the ones we think you should deliberately leave open for now.
We build what your team can maintain
A procedure that only works while a consultant is on site has not solved anything. Documents are drafted with the people who will own them, at the level of formality the site can actually sustain.
We will tell you not to hire us
If the issue is capacity rather than capability, or if it is genuinely low-exposure, that is what the orientation call will conclude. It costs us a project and earns the next three.
We stay independent
No software resale, no vendor referral commissions, no certification body affiliations. Our recommendation is not shaped by what we would earn on the implementation.
Traditional GMP consulting was built to answer "are we compliant?"
That question has a report as its answer, and for a long time a report was enough. It is not what a quality team is measured on now. Today the questions are sharper and they are commercial as well as regulatory: will we pass in March, why is release taking eleven days, which of these forty findings actually matters, and how do I get this funded by people who do not work in quality.
We built this practice around those questions instead. Diagnose early, rank by exposure, put a number on inaction, build the solution with the team that will own it, then verify that it held. The compliance expertise is the same as anyone credible would bring. What differs is what we do with it.
What we are, and what we are not
We are an independent advisory. We are not a notified body, a certification body, or a regulator, and nothing we issue constitutes a licence, a certificate, or a regulatory approval. Where a Qualified Person decision is required, that decision remains with your QP. Where our advice touches on legal obligation, we will say so and recommend you take legal counsel alongside it.
EU GMP
Part I & II, Annexes 1, 11, 15, 16
ICH
Q7, Q9, Q10 and the quality system expectations behind them
GDP
Distribution, transport qualification, responsible person
ISO
13485 and EU MDR technical documentation
Engagements run in English and Dutch, on site across the Netherlands and Belgium, or remotely where the work genuinely permits it. Confidentiality agreements are signed before any site information is exchanged.
Tell us where the pressure is
A backlog you cannot clear, an inspection you know is coming, a client audit you passed by a narrower margin than you would like. Start there. An orientation call commits you to nothing.