We have a simple aspiration

Our toxicology consulting services provide the highest standard of chemical hazard and risk assessment across the broadest range of industries and organisations. We aim to help our clients cope with the complex and ever-changing regulations framed to protect human health, and we endeavour to do this in a way that meets their time and budgetary constraints.

Our expertise

Hazard Characterisation

Our hazard assessments, generally based on in-depth searches of the scientific literature, aim to define the dose-response for all routes of each of a chemical’s toxicological propensities.

Risk Assessment

Our health risk assessments convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure.

Literature Searching

Robust risk assessments rely upon quality data. We are experienced searchers of major toxicity databases, giving us valuable access to Expert Group and primary reports.

Industries we work in

Our toxicology consultants have extensive experience, enabling
us to help our clients across various industries and sectors

Extractables + Leachables

We provide valuable support to the pharmaceutical, medical device and processing equipment industries by producing screening reports and, if warranted, full risk assessment reports relating to extractables and leachables (E&L).

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Medical Devices

We are adept at conducting biocompatibility assessments and biological safety evaluations of medical devices in compliance with ISO 10993, FDA and European guidelines, to help bring your device to market.

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Nicotine Products

We provide valuable advice on toxicological issues relating to e-cigarettes (and other nicotine delivery devices), and can support your regulatory submissions within the scope of EU TPD, UK TRPR and the US FDA PMTA.

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Food + Food Contact

Over many years our scientists have been providing independent assessments of the risks of chemical contamination of food and drink.

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At bibra we understand the importance of industry-specific knowledge – when people ask us what we do and how we can help them, we reply that we have one area of core expertise – toxicology – that we stick to, and do, exceptionally well.

Check out our latest blogs and case studies

Determining a suitable read-across surrogate for a pharmaceutical impurity

Case study

Following analytical studies on an intravenous drug product, an organic leachable from the container closure system (CCS) was detected, identified and quantified.

Literature monitoring for an industry group

Case study

The scientific literature can provide an early indicator of potential changes in the regulatory status of chemical substances. Organisations representing different chemical sectors may therefore provide services to their members that keep them up to date with the latest relevant publications on the toxicology of their chemicals in humans and other animals, as well as their persistence in the environment.

In silico assessment of impurities in a pharmaceutical

Case study

The client presented us with the structures of a number of impurities in a medicine currently in development for advanced cancer indications.

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