Your life sciences partner across the entire product lifecycle

QbD Group is the European Expert specialized in quality assurance, regulatory compliance, clinical services and digital solutions for the Medical Device, IVD, Pharma and Biotech industry.

QbD Group is a service partner for companies worldwide to ensure they meet the highest quality and safety standards, from idea to patient.

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Trusted expertise

Over 750 specialists with deep expertise across a wide range of life sciences sectors, offering unmatched knowledge and insights to address complex challenges.

Full lifecycle support

Providing comprehensive solutions at every stage, from early-stage development through to patient care, ensuring seamless progression of your projects.

Tailored solutions

Delivering fully integrated services, customized to your unique needs, ensuring efficient and effective solutions from start to finish.

Regulatory expertise

Offering extensive expertise in navigating global regulatory landscapes, ensuring smooth and compliant pathways for your products.

Agile integration

Seamlessly integrating with your team, adapting to your specific requirements with flexibility and responsiveness to deliver results.

Global presence

Delivering high-quality services across Europe, China, Latin America, and beyond, enabling you to access key markets worldwide.

Industries we cover

We specialize in supporting life sciences companies across various key industries.

With expertise in each sector, we help navigate complex challenges to bring innovative products to market efficiently and compliantly. Discover more about our core industries here.

Case Study - Helping Abraca BioSystems to obtain ISO 13485 certification

Pharma & Biotech

Medical Devices

In Vitro Diagnostics

Our services

QbD Group offers a comprehensive suite of services that cover critical areas in life sciences product development, launch and commercialization.

Explore our 8 specialized services designed to ensure success at every stage.

Regulatory Affairs

Quality Assurance

Lab Services

Qualification & Validation

Vigilance

Clinical

Software Solutions & Services

Toxicology

Latest news

4 Dec 2024

QbD Group announces acquisition of SciencePharma,...

29 Oct 2024

Salma Michor Appointed as Head of Regulatory Affairs...

21 Jun 2024

Annual Update event on the QbD Research Chair for Precision...

31 May 2024

QbD Group Once Again Awarded Gold Label as Best Managed...

Insights & resources

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.

Webinar

From Requirements to Code: a unified MDSW development cycle that covers all requirements

Watch our webinar on demand to master medical device software development. Learn about IEC standards, cybersecurity, AI integration, and FDA expectations.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

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