Pharmaceutical Toxicology Services

Expert toxicological risk assessments

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.

10+ years of expertise

Our toxicologists bring over a decade of specialized experience in pharmaceutical toxicological risk assessments.

10,000+ reports delivered

A proven track record of delivering comprehensive toxicology reports across a wide range of pharmaceutical applications.

Trusted by 600+ clients

Pharmaceutical companies worldwide rely on our toxicology expertise to ensure product safety and compliance.

60+ countries served

Our global reach ensures toxicological expertise wherever your products are manufactured or marketed.

Industry context

European Leaders in Toxicological Risk Assessments

QbD Group is recognized as a European leader in toxicological risk assessments for the pharmaceutical industry. Our EUROTOX-certified experts combine deep scientific knowledge with practical industry experience to deliver actionable insights.

Comprehensive expertise: From elemental impurity assessments to extractable & leachable studies, our team covers the full spectrum of pharmaceutical toxicology needs. We support container closure systems, manufacturing equipment, and process validation.

Regulatory compliance: Our assessments align with ICH Q3D, ICH M7, and other relevant guidelines, ensuring your products meet the most stringent regulatory requirements across global markets.

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.

Offerings

What we offer9

Elemental Impurities Reports

Ensure compliance with elemental impurities regulations through QbD Group's expert risk assessments and tailored reports.

Environmental Risk Assessment (ERA)

Assess the environmental profile of your pharmaceutical products with our detailed report. Identify and mitigate the environmental risks.

Extractables & Leachables Reports

Our extractables and leachables reports meet the highest quality standards. With rigorous scientific methodology and deep industry expertise.

Monitoring Studies

Keep up to date with standards and ensure the safety of your product. With more than 10 years providing Toxicology Services, membership to AETOX and certified by EUROTOX.

Nitrosamine Risk Assessment

Elaboration of comprehensive Nitrosamine Risk Assessment reports to ensure pharmaceutical product compliance with regulatory requirements.

Organic Impurities Reports

We carry out toxicological evaluations of organic impurities according to ICH Q3A/B, assessing the toxicological risk and establishing a safety limit.

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.

REACH Registration & Compliance

Get expert support for REACH registration: substance ID, IUCLID dossiers, SDS, and CSR. Ensure compliance and streamline submissions with QbD Group.

Residual Solvents Reports

Ensure compliance and patient safety with QbD Group's residual solvent risk assessments, tailored to meet regulatory standards.

Why QbD Group

Your trusted partner

QbD Group's toxicology team combines EUROTOX certification with deep pharmaceutical industry experience. We deliver efficient, risk-based toxicological assessments that keep your products compliant and safe.

End-to-end toxicology support

from initial risk assessment to final reporting, we cover every aspect of pharmaceutical toxicology.

Trusted expertise at scale

with 10,000+ reports delivered to 600+ clients, our track record speaks for itself.

Proactive compliance monitoring

we stay ahead of evolving regulations to keep your products market-ready.

Certified Toxicology Experts

our EUROTOX-certified team brings the highest level of scientific rigor to every project.

Let's talk Toxicology

From risk assessments to regulatory compliance, our toxicology experts are ready to support your pharmaceutical needs.