A trusted consultancy, run by experienced toxicologists
Feeling festive? Check out our tox-themed advent calendar
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).
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.
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.
Food + Food Contact
Over many years our scientists have been providing independent assessments of the risks of chemical contamination of food and drink.
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.
Knowledge is key. Part 1: Toxicity literature searching, a personal history
Blog articles
Our Toxicology Director, Peter Watts, has written a very interesting article focussing on toxicity literature searching, from his own perspective (having been at bibra for 40+ years)
Evaluation of the endocrine-disrupting potential of a plant protection product
Case study
The Plant Protection Products Regulation (EC) No 1107/2009 is amended by Regulation (EU) 2018/605, requiring that information on the potential endocrine-disrupting properties of such products must be collated and evaluated. The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have published “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009”, detailing the performance of such hazard identification, together with an Excel spreadsheet to be used as a template for gathering the necessary information on “human and animal health” and “non-target organisms”.