We accelerate the development of your innovation, securing fast access to patients. We ensure confident growth through regulatory compliance and operational excellence.
700+
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.
700+ 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 awarded Platinum label as Best Managed Company 2026, marking seven consecutive years of recognition for excellence in the life sciences industry.
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At QbD Group, we are joining forces with Vigintake to support the evolution of pharmacovigilance operations through intelligent automation and innovative digital solutions, combining regulatory expertise, quality systems, and advanced technology.
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QbD Group today announces the acquisition of Rescop, a specialist in GxP compliance, computer system validation, and validation software for the life sciences industry.
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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 & 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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White PaperA comprehensive overview of the state of the art in Advanced Therapy Medicinal Products (ATMPs) as of June 2026 — covering EU regulation, cutting-edge manufacturing, evolving quality standards, and the business strategies shaping the future of gene, cell, and tissue therapies.
Case StudyDiscover how QbD Group helped Techdow Pharmaceutical, a leading Chinese exporter of complex biologicals, achieve EU GMP certification, Marketing Authorisation, and full commercialisation across Europe.
Case StudyDiscover how QbD Group helped Henlius, a China-based biopharmaceutical company, achieve full regulatory compliance and launch in the EU within 3 months of Marketing Authorisation grant.
White PaperAs pharma SMEs and biotechs grow, pharmacovigilance systems that once worked well can quickly become a bottleneck. This white paper breaks down how to build a pharmacovigilance (PV) setup that scales with your business, without losing compliance or control.
BlogNot every CRO is equipped for IVD performance studies. Learn the nine capabilities that matter most for compliant, defensible evidence generation.
BlogExplore the three main sponsorship models for combined IVD-drug studies and learn how governance structures impact compliance, timelines, and data ownership.
BlogUnderstand the difference between delegating operational tasks and transferring Sponsor responsibilities in IVD performance studies under IVDR and FDA frameworks.
BlogLearn who carries Sponsor responsibility in IVD performance studies and why this role shapes compliance, data ownership, and regulatory success.
WebinarAs pharmaceutical organizations grow and evolve, Lifecycle Management becomes increasingly difficult to control. This webinar explores how complexity develops across Regulatory Affairs and Pharmacovigilance, and how to structure activities in a more scalable and cost-efficient way.
BlogDiscover why AI pilots in pharma often fail before production and how governance, workflows, and data foundations determine success.
BlogDiscover how MedTech's validated AI approach can help pharma accelerate compliant AI adoption across R&D, clinical trials, and GMP operations.
BlogDiscover why governance, validation, and trust, not model performance, are the real challenges for AI adoption in life sciences.
Let our experts help you navigate the complexities of life sciences regulation and quality.
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