Toxicology Assessment

• 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.

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

• 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.

• 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.

• 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).

• 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.

• 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.

• 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.

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.

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

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

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

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