Toxicology - for maximised safety

Within pharmaceutical safety we can assist at multiple stages of the development from early stage up to clinic. We can evaluate target safety assessments for active ingredients, provide mutagenicity assessment of impurities under ICH M7 guidelines, write weight of evidence (WoE) report for waiving studies according to ICH S1B(R1) or calculate appropriate human equivalent dose (HED) for clinical studies.

Additionally, we also provide safety evaluation of pharmaceutical excipients and calculation of safe doses for new formulations for generic and biosimilar pharmaceuticals.

We are experienced in biocompatibility assessment of medical devices of all classes and can provide support in writing and reviewing your Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) according to ISO 10993 and ISO 14971 or other relevant standards such as the ISO18562 series. We can also help you carry out the necessary tests and subsequent evaluations required for toxicological and biological risk assessment reports for your medical device. Our toxicologists can provide advice, guidance and interpretation of results for submission to the relevant authorities. 

We also offer regulatory advice, study monitoring services and toxicological safety evaluation of ancillary medicinal substances in medical devices and of combination products.  

We work with a broad variety of chemicals and can assist with evaluating their safety, outsourcing studies and making testing recommendations depending on intended use. Our expertise includes calculation of permissible daily exposure (PDE), acceptable daily intake (ADIs), margins of safety (MoS) or risk characterization ratios (RCR). 

Additionally, we work within the REACH regulation and can provide expertise in writing chemical safety reports (CSR), testing proposals, waiving of studies, read-across approaches and provide guidance for your chemical REACH registration.

We can assist with evaluation of cosmetic ingredients as well as outsourcing of studies in line with European regulation (EC) No 1223/2009 on cosmetic products. Our services include comprehensive toxicological risk assessments, Cosmetic Product Safety Reports (CPSR), and support with Product Information File (PIF) preparation.  

We can aid in assessing the risk of substances used in production and calculating Occupational Exposure Limits (OELs) and Occupational Exposure Bands (OEBs) for new chemicals in order to protect workers. This assessment includes hazard assessment, identification of significant effects, exposure estimations, calculations and recommendations to ensure workplace safety and is relevant within pharmaceutical, chemical, food, cosmetic and medical device manufacturing. Additionally, recommendations for appropriate risk management measures and personal protective equipment (PPE) can be provided.

We offer evaluation of ecotoxicological safety and environmental distribution and can calculate ecotoxicological risk indices such as the predicted environmental concentration (PEC) and predicted no-effect concentration (PNEC) in order to understand potential safety concerns to the environment.

We have expertise with computational approaches within toxicology such as quantitative structure-activity relationship (QSAR) modelling, read-across and toxicokinetic modelling. This can be used to assist you in the selection of safer compounds at an early stage of your product development, even before experimental testing has been initiated. These approaches can be used to plan testing strategies for new products.

Additionally, we have experience working within the safe and sustainable by design (SSbD) framework and are committed to helping develop safer products.

We are happy to offer tailor-made lectures in general toxicology, risk assessment, environmental toxicology and any of the other areas listed above.