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Services — hire me for the craft itself

Five services. One specialism.

The same job, done faster.

Pharmaceutical quality and compliance, from RP responsibility to training. On every job my AI know-how simply works along — so you already save time, energy and money while the work gets done.

01 RP

Responsible Person services

Ask about RP services

Permanent, interim or as backup: I take on the RP responsibility for your wholesale licence — rooted in thirty years of GxP experience.

What you get

  • Oversight of your quality system, recalls and complaint handling
  • Point of contact towards the IGJ during inspections
  • Self-inspections and supplier/customer qualification

AI works along

Self-inspection: 10 hrs → 2 hrs. The same AI method from my own RP practice, applied to your self-inspections and document review — the RP signs off, not the machine.

02 Interim

GxP/MDR interim consultancy

Plan an interim engagement

Audits, remediation and inspection readiness — with someone who knows audits from both sides: passed and performed.

What you get

  • Audits and self-inspections, performed or supervised
  • Remediation after findings — from CAPA to re-inspection
  • Inspection readiness: IGJ, WHO, notified bodies

AI works along

A dossier in days, not weeks. Document review and findings reporting with AI support; every finding is verified before it enters the dossier.

03 Training

Compliance training

Ask about training

GDP/MDR masterclasses and quality trainings, built on real casework — like the GAMP 5 training for a robotised pharmaceutical warehouse.

What you get

  • Tailor-made GDP/MDR masterclasses and quality trainings
  • GAMP 5 training for automated systems
  • Assessment and certification per employee

AI works along

Tailor-made, without the tailor-made lead time. Trainings are developed and deepened with AI: interactive, with assessment and certification — fitted to your operation faster than classic custom work.

04 Analysis

Gap analyses

Plan a gap analysis

Your QMS set against current GMP, GDP and MDR requirements — with a report you can act on immediately.

What you get

  • A comparison of your QMS against current regulation
  • A report with findings, priorities and actions
  • Every finding with a source reference, for review by your QP

AI works along

A source reference per finding. AI compares your documentation against the requirements and references the source per finding — you and your QP keep the final say.

05 Change

Change management

Discuss your change programme

Compliance implementations that work in practice, not just on paper — from new requirements to new ways of working.

What you get

  • Implementation of new requirements and ways of working on the shop floor
  • From SOP and training to behaviour and assurance
  • Buy-in from the quality team and the operation alike

AI works along

Documentation keeps pace. SOPs, work instructions and training material are updated faster with AI — so the new way of working is properly anchored.

White-label · for suppliers to pharma

Do you serve pharmaceutical companies? Earn online on the side.

For the many firms serving pharmaceutical companies — consultancy, training, recruitment — the compliance dashboard is available white-label. Your knowledge becomes a (to-be-built) module under your own brand: earning online, without deploying staff.

Imagine: training firm PharmAcademy puts its GDP training in the dashboard as a module. Clients complete training, assessment and certification online at app.pharmacademy.nl — without anyone from the firm sitting in.

Explore the white-label opportunity
  • No staff required
    Your knowledge keeps earning online, 24/7
  • Your brand and rates
    Your own environment, your own clients
  • A module built to fit
    Built on your knowledge base — only if it demonstrably pays off
Not sure where to start?

Start with the AI Compliance Scan

One conversation, one report — and you know per process where AI demonstrably pays off in your compliance operation, before you build or hire anything.

More about the Scan

Contact

Tell me what job needs doing

You will hear concretely what I can do for it — and what my AI way of working saves you during the job. A first conversation is free of obligation.

Book a call Call +31 6 1008 2389
FRANK@REALAXCES.NL