• There are no suggestions because the search field is empty.
Safeguarding-Drugs-Controlling-Elemental-Impurities-ICH-Q3D

Toxicology

QbD Group offers a set of 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 pharmacological 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.

Monitoring studies

QbD offers comprehensive support for laboratory studies, method assessments, and final report reviews..

Impurities

QbD has a professional team of expert toxicologists to develop any evalutions of impurities in pharmaceutical products, support your production process & compliance with regulations.

Toxicology reports

QbD offers the largest database of high-quality toxicology reports, PDE & OEL certified by AETOX members. Our expert toxicologists can develop customized reports on demand.

Environmental toxicology

Find out how we can help solve your ecotoxicology requests and address your environmental health questions.

Market trends & challenges

Toxicology plays a vital role in assessing the safety and risks of chemicals, pharmaceuticals, and industrial products. With evolving regulations and industries, there is a growing demand for more rigorous safety assessments. Advances in technologies like AI, ML, and high-throughput screening are revolutionizing the field, enabling faster and more accurate evaluations.

Environmental toxicology is gaining attention, focusing on the impact of substances on ecosystems. Managing large datasets and ethical considerations, such as reducing animal testing, are significant challenges. At QbD Group, our toxicology experts leverage these advancements to provide reliable and innovative solutions.
Why-self-inspections-or-internal-audits-are-essential-for-your-QMS-1536x864

 

Our offerings for Toxicology in

PDE-OEL Reports

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...
Nitrosamine Risk Assessment

Nitrosamine Risk Assessment

Elaboration of comprehensive Nitrosamine Risk Assessment reports to ensure pharmaceutical product compliance with regulatory requirements regarding nitrosamine...
Organic Impurities Reports

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.
Extractables & Leachables Reports

Extractables & Leachables Reports

Our extractables and leachables reports meet the highest quality standards. With rigorous scientific methodology and deep industry expertise, we help you ensure the...
Environmental Risk Assessment (ERA)

Environmental Risk Assessment (ERA)

Assess the environmental profile of your pharmaceutical products with our detailed report. Identify, and mitigate the environmental risks associated with the life cycle...
Monitoring Studies

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...
Keyvisual_Business & Communications

Why QbD Group?

QbD Group supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient.

With more than 10 years providing Toxicology Services, QbD Group is your partner for advice and support on controlling quality risks.

Our Toxicology Team is member of AETOX organization and the experts are certificated by EUROTOX.


Experience-icon

10+ years of experience

Full-cycle-support-icon

Full lifecycle support

globe-3

Global presence

Best-Managed-Company-icon-2

Best Managed Company

 

contact-mail

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. 
B&C_Get in touch-1

Resources

preview_image
Case study

Ensuring pharmaceutical production quality: cleaning validation for government agency

Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval.
preview_image
Case study

Guiding KU Leuven's glioblastoma research to the clinic with precision business planning

Helping KU Leuven advance glioblastoma research to the clinic with strategic business planning, funding support, and a roadmap for clinical impact.
preview_image
Case study

Optimizing pharmacovigilance for a biotechnology leader

Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.
preview_image
Case study

Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

QbD Group has facilitated the launch of a new drug production line for treating hemophilia, overseeing the qualification of over 100 pieces of small-scale supporting equipment.