PDE-OEL Reports
We have a professional team of expert toxicologists to calculate the PDE value of any API and we offer the largest online library of high quality PDE reports available...
Pharmaceutical Toxicology Services
QbD Group offers a set of pharmaceutical toxicology services, for your processes, applications, and equipment. We are EUROTOX certified and are members of AETOX.
Our efficient and well-structured risk-based approach provides the right focus to ensure that your pharmaceutical products meet high-quality requirements and regulations.
Our consultants bring a wealth of expertise in toxicology, providing valuable support to your team or facilitating the efficient and practical execution of your projects through outsourcing.
European Leaders in Toxicological Risk Assessments
We deliver comprehensive toxicological risk assessments, backed by a team of ERT-certified toxicologists whose expertise ensures regulatory approval and patient safety.
Recognized for our experience, trusted by leading companies, and valued worldwide, we are a global reference in toxicological risk assessments
Proven Experience
10+ years providing trusted toxicology expertise
With over a decade of experience, we are recognized for providing scientifically robust assessments that regulators and industry stakeholders rely on.
Recognized Industry Leadership
10,000+ expert reports delivered
Our delivery scale and consistent regulatory acceptance position QbD Group as a recognized leader in pharmaceutical toxicology.
Trusted Worldwide
600+ clients in 60+ countries
Pharmaceutical, biotech, and chemical companies worldwide rely on our toxicology assessments, consistently accepted by authorities and aligned with global regulatory expectations.
Regulatory-Grade Quality
Reports built for audits and submissions
All reports are prepared and peer-reviewed by accredited toxicologists using validated methods, full traceability, and transparent rationale to ensure technically defensible, inspection-ready assessments.
Our offerings for Toxicology in
All
- All
- Pharma & Biotech
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Why QbD Group?
- End-to-end toxicology support
From early development to post-approval changes, we provide integrated risk assessments seamlessly aligned with QA, CMC, and regulatory strategies. - Trusted expertise at scale
With decades of combined experience across diverse projects and markets, our toxicology team provides reliable insights that add efficiency, consistency, and confidence to every assessment. - Proactive compliance monitoring
Through strict oversight of reports, we help clients stay in full control of toxicology obligations, proactively alerting them to potential non-conformities before they become risks. - Certified Toxicology Experts
Our reports are prepared and reviewed by EUROTOX-certified (ERT) toxicologists, ensuring the highest standards of scientific quality, regulatory reliability, and patient safety across every assessment.
End-to-end toxicology support
10+ years of experience
Compliance monitoring
Certified toxicology experts
Get in touch
From ensuring compliance to optimizing processes, our Quality Assurance experts are ready to support your journey to excellence. Reach out today and let’s ensure your operations meet the highest industry standards.
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Ensuring a smooth MDR transition for Oystershell's medical devices
The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
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