Manufacturers and wholesalers
Holding a GMP or GDP licence and needing extra QA capacity or an independent review.
Quality Assurance · GMP & GDP · Benelux
Quality assurance and GMP consultant for the Benelux
Support with GMP and GDP compliance, audits and your quality management system (QMS) across Belgium, the Netherlands and Luxembourg.
How we support you
- GMP and GDP compliance: building, reviewing and improving your quality management system (QMS)
- Setting up and maintaining SOPs, quality manuals and documentation control
- Inspection and audit readiness: preparation, hosting and follow-up
- Supplier audits and qualification of suppliers and contract partners
- Deviations, complaints, change control and CAPA: investigation, documentation and follow-up
- Serialisation and Falsified Medicines Directive (FMD) compliance, and follow-up with FAMHP and CBG-MEB
GMP and GDP in Benelux practice
GMP and GDP requirements are European, but inspections are local. We combine the European guidelines (EU GMP Annexes, GDP Guidelines) with the practice of Belgian, Dutch and Luxembourg inspectors, so your quality system holds up during an inspection and not only on paper.
Who we work for
MAHs and international companies
Setting up quality oversight of contract manufacturers and distributors in the Benelux.
Growing organisations
Building a quality management system or preparing for a first inspection.
How we work together
1. Exploration
We discuss your quality system, licences and bottlenecks in a no-obligation conversation.
2. Concrete proposal
You receive a clear proposal with scope, approach and planning.
3. Execution
An experienced QA consultant works with your team until the result is achieved.
Ready to discuss a compliance project or need?
Tell us where your team needs support. We will contact you personally.