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Toxicology Assessment

Conducting Chemical Hazard Analysis and Risk Assessment to Protect Public Health

Toxicology plays a key role in product development, regulatory authorization, and ongoing product stewardship including product modifications, and post market compliance.  

As a responsible manufacturer, you have a duty of care to understand the toxicological impact of your ingredients, excipients, device, and closed container systems.  

scientific testing with a pipette

Toxicology Insight and Advice

Our team of expert toxicologists will assess the potential toxicological impact associated with your consumer or pharmaceutical product at every stage of its lifecycle, providing insight into chemical or biological exposures and their potential risks. 

Projects range from the assessment of a single chemical or microorganism to a whole product, and we offer toxicology consulting across a wide range of industry areas, including:

Our Toxicological Expertise

We can assist with the development, manufacture, and post market compliance requirements to support your products to market:

  • Consultancy services across the product stewardship lifecycle
  • Biocompatibility of devices and delivery systems
  • Extractables and leachables (E&L)
  • Microbial assessments and audits
  • In vitro and in vivo study design, monitoring, and reporting
  • Human and animal health risk assessments
  • Dossier compilation for nonclinical regulatory submissions
scientists-wearing-safety-goggles

Key Areas of Focus for Our Toxicologists Include:

Hazard Identification
  • A comprehensive range of databases tailored for specific endpoints are searched to inform on potential chemical hazards.
  • In-silico screening using (quantitative) structure-activity relationship models and expert review.

Toxicity Profiling
  • Summary profiles for individual chemicals tailored to specific regulatory pathways.
  • Pharmacological, pharmacokinetic, and toxicological information based on published studies, aligned with hazard screening data.

Literature Reviews
  • Systematic review methodologies are applied to retrieve and evaluate relevant sources.
  • Critique of empirical studies to contextualize reported findings and inform the weight of evidence.

Quantitative Risk Assessment (QRA)
  • Dose-response assessment.
  • Identification of health-based guidance values.
  • Margin of exposure and margin of safety calculations for single ingredients, impurities, reaction, and degradation products.

Extractables and Leachables (E&L)
  • Developing appropriate safety concern thresholds and analytical evaluation thresholds in collaboration with our in-house analytical chemistry team.
  • Extractables data is assessed to identify leachables of potential concern, for inclusion in the targeted leachables panel.
  • Leachables Quantitative Risk Assessment (QRA).

In Vitro and In Vivo Study Design and Management
  • Assistance with selecting qualified testing partners.
  • Designing fit-for-purpose testing strategies to generate the required data within budget and timelines.
  • Advising on the most appropriate cell line, model, or species, exposure methods, and dosing.

Wherever possible we aim to reduce the need for in vivo studies. Our toxicologists work hard to define alternative strategies to reduce or remove the need for in vivo studies if regulatory requirements allow. In vivo studies are, therefore, only performed when an essential step in delivering a product to market.

Microbial Assessment
  • Pesticidal registration (antimicrobials).
  • Anti-microbial resistance assessment and mitigation.
  • Pre-emptive microbial risk assessment management of the supply chain.
  • RCA and recall management after microbial contamination events.
  • Inspections and audits performed by HACCP, ServSafe certified toxicologists.

Classification, Labelling, and Packaging (CLP)

  • Assessment and conclusion of the hazard classification of chemical substances and mixtures.
  • Determination of the necessary, safe use information required in the safety data sheet.
  • Development of intelligent testing strategies, focusing only where testing is necessary for accurate product classification.
  • Preparation of expert opinions on labelling according to CLP and EU regulations.

Our Toxicology Consultancy Services

Implementing robust chemical and biological risk assessment programs is essential for protecting public health and corporate reputation. We understand the importance of specific industry expertise and knowledge. Our consultants have the breadth of experience and capabilities to manage your project by building bespoke strategic frameworks for regulatory approval, risk mitigation, and post market surveillance and reporting.

Toxicology Consultancy for Specific Regulatory Pathways

Ensuring test design and strategies will generate the data needed to support the chosen regulatory pathway. Advice on bridging strategies across regulatory submissions or across product iterations.

Gap Analysis and Independent Reviews of Existing Studies

Independent review of existing toxicology study data, including gap analysis to identify additional data requirements and advice on addressing data gaps and deficiencies.

Human and Animal Health Risk Assessment

A robust and comprehensive approach is applied to the assessment of chemical and biological data in line with industry-approved standards and regulations.

Regulatory Nonclinical Narratives and Technical Reports

Authoring clear scientific documents and summary narratives for regulatory submissions which showcase the strength of the toxicological data.

Scientific Communications

Interactions with regulatory authorities, preparation of 'white papers', journal articles, posters, presentations, and consultation documents.

A Tailored Approach

Each inquiry is assessed with a tailored approach from an expert toxicologist with experience in your industry sector.  All projects start with a strategy definition phase to ensure we fully understand your project needs and objectives.   

We work as an extension of your in-house team to build a long-term partnership that supports your business success through a deep understanding of your current and future business needs. 

Our toxicologists bring: 

  • Years of in-house and consultancy experience across a range of industries
  • Independent analysis and insight into assessing risks and how to mitigate them 
  • Robust technical knowledge of specific chemical and biological tests and limitations which may impact results 
  • Guidance on efficient, cost-effective novel products and formulations, partial datasets, and deficiencies to ensure regulatory approval

 

Broughton Scientists Testing

Speak to an Expert

Speak with a toxicologist to discuss your project and learn how we can help accelerate your product to market to maximize your success.



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Consultancy services resources 

Learn more about how we can help bring your product to market through our scientific and regulatory consultancy services.

Toxicology-Advice-and-Consultancy-Services

Toxicology Advice and Consultancy Services

Our team of in-house toxicologists reviews and evaluates toxicological data on a wide range of chemicals to produce independent expert opinions on risk assessment. We then advise on the strategies to mitigate or reduce those risks to protect corporate reputation and public health.

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Pharmaceutical-Services---Extractables-and-Leachables

Pharmaceutical Services - Extractables and Leachables

The evaluation of extractables and leachables (E&L) is an essential component of the pharmaceutical development process.

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Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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