GMP and GDP compliance services
Truex Consultancy provides GMP and GDP compliance services to pharmaceutical, biotech and medical device companies in the Netherlands and across the European Union. Every engagement is led by a senior quality professional. Choose a service below to see what it covers, how we work and what you receive.
Nine ways we support your quality organisation
Responsible Person for GDP
A qualified RP named on your wholesale distribution authorisation, on an interim, part time or standby basis.
Interim QA and QP support
Senior quality professionals who step into a vacancy or a project and deliver from week one.
GMP audits and gap assessments
Independent audits with findings that are classified, risk ranked and paired with a workable remediation plan.
Supplier qualification
Risk based qualification of API, excipient, packaging, contract manufacturing and logistics partners.
QMS development and remediation
Build a quality system from nothing, or repair one that has grown too heavy to use.
Inspection readiness
Preparation, on site support and response drafting for IGJ, EMA coordinated, FDA and customer inspections.
Data integrity
ALCOA+ assessment of paper, spreadsheets, instruments and computerised systems, with a remediation plan.
Deviation, CAPA and risk
Investigations that find the real cause, CAPAs that hold, and a backlog that finally closes.
Strategic advisory
Licence applications, site transfers, integrations and remediation programmes, managed end to end.
Operational efficiency in GMP environments
Waste taken out of regulated operations. Leaner processes and smarter testing that stay defensible.
Who we work with
Our clients are marketing authorisation holders, contract manufacturers, wholesale distributors, biotech companies moving from development into supply, and medical device firms with a pharmaceutical component. Some have a full quality department and need an independent view. Others have one person carrying the whole quality system and need capacity.
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. That is a clear picture of where you stand, and a plan that can actually be delivered with the people you have.
How we are different
Three things shape the way we work.
Senior delivery. The person who scopes your project is the person who does the work. Nothing is handed to a junior consultant once the contract is signed.
Proportionate advice. A quality system has to fit the company that operates it. We do not import a large pharmaceutical model into a company of twenty people, and we do not accept a thin system in a company that ships to multiple markets.
Findings with a route out. An audit report that lists problems without a sequence for fixing them is of little use. Every report we issue ranks findings by risk and sets out what to do first, who should own it and how long it should take.
Where we operate
We work on site throughout the Netherlands and Belgium, and travel across the European Union for audits and inspection support. A large part of the work, including document review, remediation planning and coaching, is done remotely. We agree the balance of on site and remote days when we scope the work, so travel cost never appears as a surprise.
What an engagement looks like
1. Orientation call
Twenty minutes on what has happened and what you need. No charge, no obligation.
2. Written proposal
Scope, deliverables, days, rate and timeline in one document. You know the cost before we start.
3. Delivery
We do the work, report progress at agreed intervals, and flag anything that changes the picture.
4. Handover
You keep the documents, the reasoning and the plan. The work does not leave when we do.
Common questions
Do you work with small companies?
Yes. A significant part of our work is with companies where one or two people carry the entire quality system. The advice is scaled to the organisation, not copied from a large manufacturer.
Can you start quickly?
For interim cover and inspection support we can usually begin within one to two weeks. Audits are scheduled by agreement, and a realistic lead time is three to six weeks so that documents can be reviewed in advance.
How do you charge?
Most work is on a day rate against an agreed number of days. Responsible Person services are usually a monthly retainer with a defined time budget. You receive the figure in writing before any work starts.
Do you sign confidentiality agreements?
Always. We work under your confidentiality agreement or ours, whichever you prefer, before any documents are shared.
We are not sure which service we need. Where do we start?
Take the free GMP self-assessment. It takes a few minutes and returns a report showing where your quality system is weakest. If it is easier, book a short call instead and we will point you in the right direction.
Not sure where to start?
Tell us what has happened and what you are worried about. We will tell you honestly whether it is something we can help with.