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
Derivation of a dermal HBEL for a hormone ester
Case study
Health-Based Exposure Limits (HBELs) are used to control risk when different medicinal products are manufactured in shared facilities.
Derivation of an intravenous PDE for a common leachable
Case study
Chemicals that leach into drug products from processing or manufacturing equipment, drug delivery systems and/or packaging may pose a health risk to patients.
Knowledge is key. Part 2: The bibra TRACE database (and supporting databank)
Blog articles
In Part 1, Peter Watts gave a potted history of his personal early experience in literature searching and toxicity data identification. Along with our colleagues of the same 'fine vintage', he weathered the storms of change, progressing from a time of back-strain (from carrying huge texts around) and index finger wear (turning pages) to dial-up and then to web-based searching. With your indulgence, Pete would now like to expand a little regarding TRACE and its value to clients and the bibra toxicologists.