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).
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.
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.
Over many years our scientists have been providing independent assessments of the risks of chemical contamination of food and drink.
We deliver assistance on toxicological issues related to regulations, hazard reviews and multi-component formulations on all consumer products, including cosmetics (and CPSRs).
If you have a product which is classified as a Plant Protection Product, whether it contains one or several active substances, our team of scientists can help.
We can expertly support your biocide regulatory submissions, and work within IUCLID to effectively bring biocidal products to market.
Companies are adding cannabidiol (CBD) and other cannabinoids to a plethora of consumer products, including foods, e-cigarettes, and cosmetics. We can assess the safety of these products, flagging any toxicological concerns and identifying potential risks (for example to vulnerable sub-populations).
Our team is adept at preparing critical toxicological reports - we regularly provide assessments of novel or unexpected impurities, excipients and other intentionally-added substances, and extractables and leachables.
We are a leading supplier of REACH compliance services, assisting chemical manufacturers, importers and downstream users comply with their REACH Regulation responsibilities.