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Supporting IVDR Compliance Through Scientific Validity Reports for Diagnostic Analyzers

Our Solutions for Life Sciences

Tailored support for Pharma, Biotech, Medical Devices & IVD companies — from idea to market readiness.

Explore our Pharma & Biotech Solutions
Explore our MedTech & IVD Solutions

 

Pharma & Biotech Solutions

Empowering life sciences innovation.
QbD Group supports pharma and biotech companies across every stage of development - from early discovery and scale-up to manufacturing - ensuring compliance, efficiency, and quality at every step.

Europe

Market Entry into the EU


Navigate complex EU regulations with confidence.

Expanding into Europe can be challenging. QbD Group helps you interpret requirements, streamline submissions, and achieve full compliance for a smooth and successful market entry.

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Guiding a global biotech company through ATMP facility qualification

Startup & Scaleup support for Biotechs

Turn breakthrough science into market-ready products.

We help biotech innovators translate discoveries into viable products. Our experts guide you in regulatory strategy, quality systems, and product development to build a solid foundation for growth.

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pharma manufacturing-1

Manufacturing Quality & Compliance

Future-proof your manufacturing.


We support pharmaceutical and biotech manufacturers in delivering compliant, efficient, and future-ready manufacturing operations amid evolving GMP expectations and increasing digital complexity. 

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Medical Device & IVD Solutions

Accelerating innovation from idea to patient.
QbD Group supports MedTech companies throughout the entire device lifecycle - from idea and design to certification, market entry, and post-market compliance - ensuring safety, performance, and sustainable growth in line with MDR and IVDR standards.
Accelerate Your Market Entry into Europe - QbD Group-3

Market Entry into the EU

Navigate complex EU medical device regulations with confidence.

QbD Group guides you through MDR and IVDR requirements, from classification and CE marking to Notified Body interactions, ensuring a smooth and compliant market entry.

Contact us
Pharma 4.0 The Next Leap in Pharmaceutical Innovation

Startups & Scaleups support for MD & IVD

Accelerate your innovation journey.

We help MedTech startups turn ideas into market-ready devices through expert guidance in regulatory strategy, quality management, and product development for sustainable growth.

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4-Nov-04-2025-10-38-31-4595-AM

Software as a Medical Device & Medical Device Software

Ensure your software meets the highest quality and regulatory standards.

QbD Group combines technical and regulatory expertise to help you develop safe, effective, and compliant medical software that meets the highest quality standards.

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