About
QM Advance

Who we are at QM Advance

The Foundation of Our Work

Inspired by science
Defined by quality
Committed to integrity

At QM Advance, we provide expert consulting in Quality Assurance and Regulatory Compliance for organizations operating under GMP, GDP, GTP, SoHO, and ATMP regulations.

We support companies in achieving and maintaining compliance with European quality and safety standards — always with a focus on patient protection, operational efficiency, and continuous improvement.

Founded by Małgorzata (Gosia) Miller, PhD, a Qualified Person (QP) and Responsible Person (RP) with extensive experience in pharmaceutical manufacturing, tissue and cell establishments, and ATMP development, QM Advance brings a combination of scientific expertise and practical industry insight.

Our mission is to translate complex regulatory frameworks into clear, efficient, and sustainable quality systems.
We help our clients prepare for inspections, design and implement quality management systems, and ensure compliance across all operations — from supplier qualification and deviation handling to audits and product release.

About the Founder - Meet Gosia Miller

gosia miller 20190502 111 edit 3

I’m a Quality and Compliance Consultant with extensive experience in pharmaceutical manufacturing, tissue and cell establishments, and advanced therapy medicinal products (ATMPs).

I work directly with clients, but operate as a BV and collaborate with trusted partners when needed — ensuring flexibility, expertise, and tailored support for each project.

I support organizations in achieving and maintaining compliance with European GMP, GDP, GTP, and SoHO frameworks — translating complex regulatory requirements into clear, practical, and sustainable solutions.

As a Qualified Person (QP) and Responsible Person (RP), I provide ongoing support for pharmaceutical operations, including daily quality assurance (QA) activities, system oversight, and continuous improvement initiatives.

With a scientific background and a strong commitment to integrity, I help clients build quality systems that not only meet compliance standards but also enhance operational efficiency and patient safety.

Connect with me on LinkedIn

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Our expertise in Action

GMP & GDP Compliance
Implementation and improvement of pharmaceutical quality systems and distribution practices in line with EU GMP & GDP.
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Tissue & Cell Establishments (SoHO)
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QA of ATMP Manufacturing & Compliance
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Quality Systems & Auditing
Development, optimisation, and review of QMS including CAPA, deviations, and audit preparation.
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RP / QP Collaboration & QA Support
Cooperation with RP/QP for batch-related QA and daily quality oversight ensuring patient and product safety
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Regulatory Strategy & Compliance Advisory
Supporting organizations in interpreting EU regulatory frameworks, preparing for inspections, and translating compliance requirements into actionable strategies.
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Support for Pharmaceutical Distributors
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