GMP · GDP · MDR · GAMP 5 · AI COMPLIANCE
Where does AI truly deliver the biggest wins in compliance?
After 30 years in the pharmaceutical and medical devices industry — as a Qualified Person, Responsible Person GDP and consultant at Teva, AstraZeneca and Bilthoven Biologicals among others, across countless departments within them — I know what matters at every level. And therefore where AI can genuinely help.
The approach
Not "adding some AI", but knowing exactly where.
GDP, GMP, GAMP 5, MDR — the requirements keep stacking up. Meanwhile, AI can do things today that were unthinkable two years ago.
The art is not adding AI because you can, but knowing exactly where it saves time, energy and money — and where people should stay firmly at the wheel. That is why I built the RealAxces AI Compliance Platform and the AI Compliance Scan: an assessment that maps out concretely where AI delivers the most in your compliance operation.
No generic chatbot, no hype — purpose-built AI, trained on pharmaceutical regulation, secure by design and aligned with the draft EU GMP Annex 22 (Artificial Intelligence).
Passed and performed.
Built by someone who has both passed and performed audits — not a software vendor viewing compliance from the outside, but a practising Responsible Person and former Qualified Person.
IGJ · WHO · NOTIFIED BODIES
From the field
Born in real work, not in a demo.
AI-assisted self-inspection · 5 departments · 2025
In my own RP practice I carried out a self-inspection of five departments with AI support: two hours instead of ten, with no concessions on depth. The platform's Audit module grew out of that experience.
GAMP 5 training for a robotised warehouse
For the start-up phase of a robotised pharmaceutical warehouse I developed and delivered a tailor-made GAMP 5 training. That project became the Training module: interactive compliance training with assessment and certification.
Every module of the platform came about this way: proven in a real compliance project first, and only then built — with human oversight as the starting point.
Working together
One starting point. Two routes. And simply hiring me works too.
Custom-built, together
We take the biggest opportunity from your report and build the solution together — trained on your processes and documents, including training for your team.
Benefits
- +Built precisely on your processes and documents
- +A one-off investment — the way of working stays yours
- +Personal guidance from a practising RP
Keep in mind
- −A higher upfront investment
- −Lead time: building and fine-tuning takes weeks, not days
Modules in the compliance dashboard
You use the dashboard modules that fit your operation — compliance Q&A, training with certification, SOP generation, gap analyses. Also available white-label for consultancy firms. Is your module still missing? It only gets built if the report shows it pays off.
Benefits
- +A low monthly entry, ready to use immediately
- +Updates and further development included
- +Expandable per module, cancel monthly
Keep in mind
- −Standard modules: more generic than custom work
- −A module for your specific process may not exist yet
Your brand up front, my platform underneath.
Imagine: quality consultancy PharmaQuality supports twelve wholesalers. Their clients log in at app.pharmaquality.nl — their own logo, their own rates, their own trainings and agents. The firm delivers AI compliance under its own name; RealAxces builds, maintains and updates the dashboard underneath.
- Your own environmentYour brand identity on your own domain
- Your own contentTrainings and agents built on your knowledge base
- Your own revenueYour rates per client, transparently split
Or hire me for the craft itself
Alongside both routes you can hire me for classic compliance work. My AI know-how simply works along on every job — the same assignment, done faster. So you already save time, energy and money while the work gets done. All services in detail →
Responsible Person services
A practising RP for your wholesale licence — permanent, interim or as backup.
GxP/MDR interim consultancy
Expert hire for audits, remediation and inspection readiness, effective from day one.
Compliance training
GDP/MDR masterclasses and quality trainings with assessment and certification, accelerated and deepened with AI.
Gap analyses
An AI-assisted comparison of your QMS against current GMP, GDP and MDR requirements — for review by your QP.
Change management
Compliance implementations that land on the shop floor, not just on paper.
About Frank
AI, tamed by thirty years of practice.
RealAxces is led by Frank van Zutphen: practising Responsible Person and former Qualified Person, with thirty years of GxP experience in pharma, biotech, medical devices and food. AI is not sold as magic here — every application is proven in his own practice first.
Working in pharmaceutical consultancy or compliance and curious where AI could strengthen your work? I would be glad to talk — no strings attached, over a coffee or online.
EXPERIENCE — 30+ years GxP
TRACK RECORD — Teva · AstraZeneca · Bilthoven Biologicals
AUDITS — IGJ · WHO · Notified Bodies
DOMAIN — GMP · GDP · MDR · GAMP 5
BASE — Amersfoort, NL
Frequently asked questions
+Where do I start?
With the AI Compliance Scan: one intake, one conversation, one report. You will then know, per process, where AI demonstrably pays off in your compliance operation — in hours per year and euros — and you choose what comes next.
+What does the intake involve?
A short questionnaire up front: who you are, which processes are in play and where the pressure sits. It takes less than half an hour, and you can fill it in online right away — feel free to skip anything you do not have to hand; the rest comes up in the conversation.
+Do I have to continue with AI afterwards?
No. The report is yours; "no AI for now" is a perfectly fine outcome. A module or custom solution only happens if the report shows it pays off.
+Who does the work — AI or a human?
AI supports, a human signs off. Every recommendation and every finding is reviewed by a practising Responsible Person, and the approach is aligned with the draft EU GMP Annex 22 (Artificial Intelligence).
+What about confidentiality?
Recordings only with prior consent, no personal or patient data in notes or reports, processing in line with the GDPR. See the security page for the full approach.
+What if no module exists for my process yet?
Then we only build it if the Scan shows it demonstrably saves time and money — as custom work (Route A) or as a new dashboard module (Route B).
+Who is white-label for?
For firms serving pharmaceutical companies — consultancy, training, recruitment. Your knowledge becomes a module under your own brand; your clients use it online without you deploying staff. More about the white-label opportunity.
Contact
Book a call
Curious where AI can speed up your quality work without losing control? A first conversation is free of obligation and concrete.
FRANK@REALAXCES.NL