Our work
Our team has many years of experience in preparing toxicological assessments required in the pharmaceutical sector. We regularly provide our clients with assessments of novel or unexpected impurities, excipients and other intentionally-added substances, and extractables and leachables.
Actives
Companies are required to generate an enormous array of data on their APIs. We are expert in summarising toxicity, ADME and pharmacology data. We also work closely with specialists in regulatory affairs and, together, we can assist in preparing the non-clinical sections of a dossier for submission.
Impurities
The toxicological assessment of impurities in pharmaceutical products poses a particular challenge as, in most cases, no substance-specific data exist. We have developed a workflow to combine our extensive expertise with in silico ((Q)SAR) models and Threshold of Toxicological Concern (TTC) concepts to establish the safety of pharmaceutical impurities.
Extractables and Leachables
A thorough assessment of potential extractable and leachable substances arising in drug products from containers and packaging is another key requirement. We have long-standing partnerships with several high-quality analytical laboratories, providing a holistic approach to the generation and evaluation of data.
Cleaning Validation
Where multiple APIs (active pharmaceutical ingredients) are produced in the same facility, it is critical to set sound toxicology-based exposure limits to ensure the safety of all pharmaceutical products. We are very experienced in following the appropriate guidance from the European Medicines Agency (EMA) and other authorities to establish these limits.
Our colleagues, Chris Waine, Peter Watts and James Hopkins, have published a paper on "The cliff-edge of toxicological concern: highlighting the potential issues of an over-reliance on "less-than-lifetime" thresholds". You can purchase this paper here, or alternatively, please get in touch with us for a free copy.
Our expertise in this area
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.
(Quantitative) Structure-Activity Relationships
We strive to help clients fill data gaps without a potentially costly and animal-intensive trip to the testing laboratory, by using computer models to predict the toxicological characteristics of an untested compound.
ADME/TK Assessments
Generating new TK data involves the use of animals, is time consuming and extremely costly (particularly if radiolabels are required). We make expert predictions, taking into account known toxicity data, structure and physico-chemical properties.
Some of our case studies in this area
Toxicology and Regulatory News June 2026: Top 5 Takeaways
Blog articles
15 Jun 2026
Stay up to date with the biggest takeaways from toxicology news in June 2026, including the EFSA’s evaluation of glycerol, the SCCS’s opinions on silver, CBD and acetophenone in cosmetics, and more.
Literature monitoring and hazard characterisation for food supplements
Case study
The client was interested in the potential adverse and beneficial effects of a number of ingredients found in food supplements and other ingested consumer products. In addition to the assessment of some defined chemical substances, the ingredients under investigation included several plant and mushroom extracts along with their key constituents.
Toxicology and Regulatory News May 2026: Top 5 Takeaways
Blog articles
18 May 2026
Stay up to date with the biggest takeaways from toxicology news in May 2026, including the EC’s evaluation of the Tobacco Products Directive and investigations into ethylene glycol’s developmental and reproductive toxicity.
