Organic Impurities Reports

Are you looking for certificated toxicology reports to support your production process & compliance with regulations?

Do you need risk assessment or toxicological evaluations of impurities in pharmaceutical products?

QbD Group offers the largest online library of high-quality available toxicology reports certificated by AETOX members.

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Why is it necessary?

EUROTOX toxicologist signs our Toxicology Impurities reports are essential for evaluating risks and impurities in the manufacturing of drugs, vaccines, biologicals, ATMP, Medical Devices, and IVD. These assessments, covering various impurities, are crucial for QA personnel, Compliance Officers, Site Directors, and Technical Directors.

The significance lies in supporting safety procedures, ensuring compliance with regulations, and safeguarding both the products and workers in the manufacturing process. The necessity arises from the need for a well-documented repository of updated certified reports, vital for audits and inspections, ultimately contributing to the overall safety of pharmaceutical production.

We can help you with Risk assessment reports and Toxicological evaluations of impurities (nitrosamines, organic impurities, mutagenic impurities, elemental impurities and impurities from extractables and leachable studies).

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

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Interested in high-quality toxicology reports or need support with risk assessments and impurity evaluations?

Our experts are here to help you ensure compliance and safety in pharmaceutical production.