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
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
The dawn of a new age in medical device risk assessments
Blog articles
After a development process that stretches back to the beginning of 2018, ISO has published the updated version of the International Standard ISO 10993-17. It has been a mammoth effort, involving over 100 scientists from 20 different countries (including bibra Senior Toxicologist, Chris Waine), and one that the toxicological and medical device worlds have been waiting for with bated breath.
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.