Toxicology - for maximised safety

We do this by evaluating the potential toxicities/hazards of emerging drug candidates, industrial chemicals, food additives and medical devices, contributing to safety assessments required for product registration or safe working environments. We can also support interactions with relevant testing facilities, regulatory authorities and the development of regulatory submission documentation in these areas.  

Our expertise covers the following areas:

Toxicological safety, evaluation and support

Our team of toxicologists can assist with a wide range of chemical or pharmaceutical safety challenges, both in terms of human and environmental health. We can prepare comprehensive risk assessment reports to meet your needs, provide project support, manage the necessary testing, assist with the target safety assessment of pharmaceuticals or collaborate on regulatory submission documents. Our toxicologists have experience with a range of regulatory frameworks covering chemical (biocides, textiles, detergents), pharmaceutical, environmental, cosmetic and medical device safety. Early toxicological safety advice for substances in therapeutic development, chemicals, cosmetics, food additives or medical devices is a wise step towards safe and sustainable by design (Ssbd) products.  

Biocompatibility and toxicological risk assessments of medical devices

We can provide support in writing and reviewing your Biological Evaluation Plan (BEP) for medical devices 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.  

Read more about biocompatibility evaluation →

Occupational exposure limits

We can provide assistance in assessing the risk of substances used in production and calculating Occupational Exposure Levels (OELs) and Occupational Exposure Bands (OEBs) to protect workers in your organisation. This assessment includes hazard assessment, identification of significant effects, calculations and recommendations to ensure workplace safety and can be carried out for pharmaceutical, chemical, food, cosmetic and medical device manufacturing. 

Computational and predictive toxicology

We can assist you in the selection of safer compounds at an early stage of your product development, even before experimental testing has been initiated. We can perform and interpret predictions of chemical properties using in silico tools or read-across approaches when experimental data are not available.   

Lectures and training

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

Getting in touch is a good start!

We provide solutions for bringing safe new medicines, chemicals and devices to market. If you are unsure whether your needs fit within the above services, please contact us and we can direct you to appropriate experts at RISE or offer tailor-made solutions.