Qualification & Validation
Qualification & Validation
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Vigilance
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Software Solutions & Services
Tox green
Toxicology
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Pharma & Biotech
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Medical devices
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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.

Explore our toxicology services

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.
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Our offerings for Toxicology in

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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...
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Nitrosamine Risk Assessment

Nitrosamine Risk Assessment

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

Elemental Impurities Reports

Ensure compliance with elemental impurities regulations through QbD Group's expert risk assessments and tailored reports for pharmaceutical products, safeguarding safety...
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Residual Solvents Reports

Residual Solvents Reports

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


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10+ years of experience

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Full lifecycle support

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Global presence

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Best Managed Company

 

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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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Resources

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Case study

Validating a Complex Autoclave Load to Enhance Sterilization Efficiency

Discover how QbD Group helped a pharmaceutical facility in Barcelona optimize and validate a complex autoclave load, improving sterilization efficiency and manufacturing flexibility.
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Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.
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Enhancing data integrity & aseptic manufacturing compliance

QbD Group helped a leading medical tech company improve MDR compliance and enhance aseptic manufacturing for long-term regulatory readiness.
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A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.
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Scalable MSAT validation support for seamless compliance & efficiency

Discover how QbD Group helped a global pharmaceutical company address fluctuating validation demands across multiple teams.
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Restoring manufacturing timelines through expert deviation management

Discover how QbD Group helped a leading biotechnology company overcome a backlog of deviations, restoring timely batch release through expert QA support.
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Guiding a global biotech company through ATMP facility qualification

Discover how QbD Group supported a global biotech company in commissioning and qualifying two ATMP therapy production sites, ensuring compliance and efficiency.
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CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.
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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.
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Optimizing pharmacovigilance for a biotechnology leader

Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.
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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.
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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.
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Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration

Discover how QbD Group's expert support enhanced a pharmaceutical company's pharmacovigilance, leading to a favorable inspection outcome by the local Regulatory Authority (AEMPS).
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The journey toward IVDR compliance for the LVOne device

QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.
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Patient Support Program (PSP)

Learn about our patient support program (PSP) and how it helps manage customer support for a PV Spanish client. Resolve quality issues and ensure stability with QbD Pharma.
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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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Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.
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Helping Relu to comply with changing regulations

QbD Group supported software company Relu with their expertise to comply with changing regulations.
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Helping Abraca BioSystems to obtain ISO 13485 certification

QbD Group helped Abraca Biosystem gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.
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Help BioLizard build their Quality Management System

QbD Group helped BioLizard document the fundamental processes of their QMS and enabled them to continue building it on their own.
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Supporting Oncomfort in developing and certifying their ISO 13485 QMS

QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System.
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Quickly bringing a new COVID-19 medical device to market

Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.
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