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Expert Quality Assurance for Biotech, Vaccines & ATMPs

Dr. Gabriela-Nadja Huetz
We turn complex compliance requirements into clear solutions – with 20+ years of GxP experience. QA Biotech Consultancy provides support within the following key areas:

Qualified
Person Services

Ensuring Regulatory Compliance
& Product Quality

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Quality
Management System

Driving Pharmaceutical Excellence &
Regulatory Compliance

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Audits and
Mock Inspections

Ensuring Supplier Quality &
Regulatory Compliance

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QA Biotech
Consultancy

QA Biotech Consultancy is an independent consulting company providing a wide range of expert Quality Assurance Service within GxP. My expertise spans from clinical study support to final commercial batch release for biotech, vaccine and ATMP products, ensuring full compliance with EU Good Manufacturing Practice (GMP) and global regulatory frameworks.

Trusted by top-tier biotech companies across Europe

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Your Trusted Expert in Pharmaceutical Quality & Compliance

Ensuring pharmaceutical excellence requires more than just meeting standards—it demands a trusted expert by your side. With my proven expertise in Qualified Person (QP) Services, Quality Assurance (QA) and Supplier Audits, I help pharmaceutical businesses safeguard product quality, achieve regulatory compliance and streamline supply chain operations. Whether you need batch release, QMS optimization, or supplier audits, I provide tailored solutions to meet your unique needs. Let’s work together to protect your product integrity and secure your market success.

Reliable Quality & Regulatory Solutions – From Production to Market

Navigating pharmaceutical regulations can be complex—but with the right partner, it doesn’t have to be. I offer end-to-end quality and compliance services, including QP Batch Release, QA Systems Development and Supplier Audits, ensuring your products meet the highest standards from production to market. My flexible approach means I can support you on a project basis or as a long-term partner. Together, we’ll strengthen your quality processes and minimize regulatory risks—ensuring your success in EU and international markets.
Pharmaceutical Quality You Can Trust – Tailored to Your Needs
In today’s highly regulated pharmaceutical landscape, quality and compliance are essential. With a personalized, hands-on approach, I provide targeted support exactly where and when you need it—from batch certification and deviation/CAPA management to supplier performance evaluations. Partner with me to strengthen your pharmaceutical quality systems and protect your market position with confidence.

Empower your organization by transforming QA & QP outsourcing into a strategic advantage.

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Mail

info@qabiotechconsultancy.com

Positioning QA & QP outsourcing as an embedded, value-driven component of your organizational ecosystem.

Mail

info@qabiotechconsultancy.com