GMP & GDP Compliance Expert
Inspection-ready.
In command of quality.
With more than 20 years of experience in pharmaceutical quality assurance, I help companies stay compliant with international GMP and GDP guidelines — from clinical development to commercial distribution, with specialized expertise in radiopharmaceuticals.
Services
What I help companies with
Practical, pragmatic, and always focused on an inspection-ready organization — from Responsible Person roles to specialist audits.
Responsible Person
GDP-compliant Responsible Person services for pharmaceutical wholesalers, including inspection guidance and QMS improvement projects.
More about RP services →Supplier Audits
Risk-based supplier audits for CMOs, API manufacturers, laboratories, and distributors — more than 650 conducted.
More about supplier audits →QA Consultancy
Setting up and improving quality systems: batch review, change control, CAPA, and document management.
More about QA consultancy →Internal Audits
Internal audits and self-inspections that go beyond a checklist — more than 350 conducted over 20 years.
More about internal audits →Radiopharmaceuticals
Specialist GMP support for PET tracers and radiolabeled medicines, including AME trials.
More about radiopharmaceuticals →Audit Training
One-day training courses for internal and supplier auditors, and a Risk Management training based on ICH Q9.
View training courses →What clients say
Experiences from clients
After a challenging Health Authority inspection, we needed an experienced Responsible Person. Boudewijn turned out to be the solution — after two years we are stronger, better, and ready for the future.
Boudewijn is a highly professional and knowledgeable Quality Auditor. All audits were well prepared and documentation was available very quickly.
Boudewijn was the instant solution for our supplier and internal audit team. Skilled, efficient, and pragmatic — able to separate the essential from the trivial.