A trusted consultancy, run by experienced toxicologists
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 & Monitoring Services
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
Medical devices and CE certification
Blog articles
A medical device placed on the EU market must have a CE (“Conformité Européenne”) certification and comply with the EU Medical Devices Regulation (MDR; Regulation (EU) 2017/745) [1] or the EU In Vitro Diagnostic Medical Devices Regulation (IVDR; Regulation (EU) 2017/746) [2]. Read our overview on the process, plus find out how we can help.
Updating REACH dossiers following ECHA Evaluation decisions
Case study
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to the European Chemicals Agency (ECHA). The Agency can, after evaluating the information provided by the registrant, require the company to update or amend their dossier, including with the addition of new experimental data. This is called a “Compliance Check decision”
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)