We accelerate the development of your innovation, securing fast access to patients. We ensure confident growth through regulatory compliance and operational excellence.
600+
Experts worldwide
1200+
Active clients
4500+
Projects delivered
200+
Years of collective working experience at global regulatory authorities
One integrated group of regulatory, quality, and clinical experts accelerating life sciences innovation across Europe and beyond.
Discover our story
Accelerate drug development with regulatory expertise from concept to commercialization.
Learn more about Pharma & biotech
Achieve compliance and market launch for your medical devices across global markets.
Learn more about Medical devices
Navigate IVDR requirements with specialized guidance and proven methodologies.
Learn more about In vitro diagnostics (IVD)
Streamline CDx development with integrated regulatory and clinical strategies.
Learn more about Companion diagnostics (CDx)
Bridge drug-device regulatory pathways with cross-functional compliance expertise.
Learn more about Combination productsWe guide your product from early strategy to post-market. By integrating deep regulatory, clinical, and quality expertise, we accelerate development, de-risk submissions, and maximize long-term asset value.
Learn more about Product developmentWe make entering and succeeding in Europe seamless. With deep regulatory expertise and local presence, we deliver end-to-end support — from strategy and submissions through importation and post-market compliance.
Learn more about Gateway to EuropeWe embed quality, compliance, and efficiency into your operations. From validation and quality systems to digital transformation and lifecycle management, we deliver fit-for-purpose solutions that strengthen your operations.
Learn more about Operational excellenceSuccess stories
From early development through post-market, we guide you at every critical stage.
600+ specialists with deep regulatory and quality knowledge across domains.
Navigate EU regulations with confidence through our unmatched regional expertise.
Bespoke strategies adapted to your unique challenges, scale, and ambitions.
On-time, on-budget execution with transparent communication at every step.
We seamlessly embed in your team culture for maximum, lasting impact.
Leverage our extensive European network and regulatory expertise to bring your products to market faster. Whatever the regulatory framework, we handle the complexity.
QbD Group has been recognized with the AEFI Award for Best Publication of 2025 for the article "Pharmacovigilance in innovative therapies: Regulatory and clinical challenges," authored by Almudena del Castillo, Head of Global Vigilance Division and Country Manager Spain.
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QbD Group and Vigintake join forces to advance the automation of pharmacovigilance and safety operations, combining deep regulatory expertise with cutting-edge technology.
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QbD Group & delaware announce a new partnership to help life sciences companies accelerate their digital transformation while ensuring full GxP compliance.
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QbD Group joins ASEBIO, strengthening its commitment to quality, compliance, and safety within the Spanish life sciences sector.
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QbD Group has been awarded the title of Best Pharmacovigilance Service Company at the latest edition of Farmaforum.
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QbD Group welcomes Dr. Diane Fairweather as Division Head Clinical, with 25+ years in global clinical leadership to strengthen and scale the division.
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QbD Group awarded Gold Label as Best Managed Company 2025, marking six consecutive years of recognition for excellence in the life sciences industry.
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Dr. Angeles Escarti-Nebot joins QbD Group as Head of Regulatory Affairs, bringing global regulatory expertise to advance innovation in life sciences.
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BlogThinking Article 5(5) is the easy route under the IVDR? Discover the hidden obligations and risks of in-house devices.
BlogDiscover when an assay used in a clinical trial falls under the IVDR and what this means for timelines, compliance, and study strategy.
WebinarDescubre el enfoque BxP para alinear BPL y BPM, cerrar brechas técnicas entre laboratorio y planta, y blindar el cumplimiento ante hallazgos críticos en auditorías regulatorias.
BlogDiscover a 7-phase AI/ML compliance framework for life sciences, covering data governance, validation, and post-launch monitoring under GxP.
BlogPharma is still figuring out AI validation. MedTech already solved it. Learn what to copy from MedTech's proven playbook to ensure GxP compliance and real-world impact.
BlogCE marking isn't just clinical and regulatory. Discover the hidden operational hurdles that delay EU market entry.
BlogDiscover why clinical strategy, not data, is the real bottleneck for EU MDR market access and how to align regulatory and clinical decisions.
BlogDiscover what non-EU manufacturers get wrong about clinical evidence under the EU MDR, from CER requirements to PMCF and data reuse.
BlogUnderstand the EU Notified Body process for medical devices, from selection to review timelines and common delays under the MDR.
BlogFDA or NMPA approval doesn't guarantee EU readiness. Discover the key gaps MedTech companies face when transitioning to EU MDR.
BlogWhat does it really take to run a successful cardiac trial in Europe? Discover key feasibility factors, from site selection to regulatory timelines and patient access.
BlogDiscover why Europe is ideal for cardiac device trials. Learn how MDR strategy and CRO support accelerate structural heart and coronary studies.
Let our experts help you navigate the complexities of life sciences regulation and quality.
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