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
EU Potential Changes to TPD
Blog articles
In April 2026, the European Commission published its evaluation of the Tobacco Products Directive and Tobacco Advertising Directive (TPD) and Tobacco Advertising Directive (TAD). The evaluation concluded that, while the existing framework has made a positive contribution to the protection of public health, it is increasingly challenged by the emergence and growing use of novel tobacco and nicotine products.
Toxicology and Regulatory News October 2026: Top 5 Takeaways
Blog articles
2 Oct 2026
October's Toxicology and Regulatory News brings together key developments across bioavailability adjustments, chemical safety, AI, particulate matter and more.
Toxicology and Regulatory News September 2026: Top 5 Takeaways
Blog articles
3 Sept 2026
September's Toxicology and Regulatory News brings together key developments from the WHO, EFSA, ECHA, OECD and more.
