What We
Do
You have important responsibilities — compliance, product safety, inspection readiness.
But your reality may look like this:
- QMS feels heavy and slows down operations
- Documentation doesn’t reflect current processes
- Inspections are approaching, and internal capacity is limited
- You need compliance that supports business — not blocks it
If that sounds familiar, you’re in the right place.
At QM Advance, we translate complex regulatory frameworks into clear, efficient, and practical systems.
No over-engineering. No document dumping. Just solutions that work — and pass inspections
Led by Dr. Gosia Miller (QP & RP), QM Advance provides specialised QA, compliance, and operational support for pharmaceutical, medical device, tissue, and SoHO organisations.
We combine technical expertise with hands-on implementation, ensuring systems that meet regulatory requirements and fit the way your organisation actually works.
Quality & Compliance Consulting
GMP & GDP Compliance
Our support blends regulatory precision with practical execution, guiding clients through inspection readiness, system improvements, and continuous compliance.
How we support:
- GMP & GDP gap assessments and inspection preparation
- Quality system remediation and improvement projects
- Deviations, CAPAs, and change control management
- Supplier qualification, technical agreements & vendor oversight
Tissue Establishment and Cell Banks
We help organizations build compliant systems that ensure traceability, donor safety, and operational reliability
How we support:
- Licensing & QMS setup for tissue and cell establishments
- Donor traceability and vigilance system design
- Quality documentation, SOPs, and risk management
- Import, distribution, and cross-border traceability models
- Regulatory liaison and inspection preparation
QA & ATMP Manufacturing and Compliance
We help organizations align their operations with GMP for ATMPs, ensuring safety, consistency, and inspection-ready practices.
How we support:
- QMS design & compliance for ATMP manufacturing
- Continuous improvement & quality metrics implementation
- Batch documentation, deviation/CAPA, and change control
- Supplier qualification & material management oversight
- Regulatory inspection preparation
Quality Systems and Auditing
Whether you need full system implementation or targeted improvements, we build structures that work in reality — not just on paper.
How we support:
- QMS implementation and optimization (GMP, GDP, GTP, ISO 13485)
- Internal, supplier, and distribution audits
- Document control and lifecycle management
- Training programs for QA, operations, and leadership
RP / QP Collaboration & QA Support
We step in as an extension of your team — to keep compliance on track, maintain oversight, and ensure regulatory expectations are met.
How we support:
- RP oversight for storage, distribution & transport
- QP collaboration for manufacturing & release activities
- Batch record review and quality documentation
- Technical agreements, supplier oversight & GMP/GDP compliance
- Daily QA support to maintain smooth, compliant operations
Regulatory Strategy & Compliance Advisory
We support early-stage and established companies in navigating complex EU regulatory frameworks with clarity and confidence.
How we support:
- Regulatory gap analyses and compliance roadmaps
- Inspection readiness and continuous compliance planning
- Interactions with competent authorities
Support for Pharmaceutical Distributors
End-to-end GDP support for companies distributing medicinal products in the EU.
How we support:
- End-to-end GDP support for companies distributing medicinal products in the EU
- Support with obtaining a Dutch wholesale distribution license
- GDP-compliant QMS setup (procedures, training, changes, deviations)
- Temperature monitoring & transport qualification
- Vendor qualification and technical agreements
- RP oversight and inspection preparation