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
The identification of oral and inhalation Health Criteria Values (HCVs)
Case study
Health Criteria Values (HCVs) are expressed in different ways, using the terminology specific to the authority that is recommending them. Oral values represent a regular ingested dose that is expected to be without appreciable risk to the consumer over a lifetime.
Pet food safety: How much do you know about what you feed your pets?
Blog articles
As they open the tin, harassed by their “best friend” or feline lodger, many pet owners must have at some time wondered about the quality of the product that they are adding to the food bowl. Click to read more about our work in pet food safety.
Medical device submissions – protecting supplier confidentiality
Blog articles
We recently described – using a fruit label as an example – how an independent consultancy such as bibra could act as a third-party broker, providing a manufacturer with a safety evaluation of a multicomponent product while also protecting suppliers’ confidentiality over chemical composition. Here, we describe another example, in this case relating to a medical device submission to a Regulator or Notified Body.