We can test and assess the potential toxicities/hazards of emerging drug candidates, industrial chemicals, food additives and medical devices, contributing to safety assessments required for market approvals. We can also support interactions with relevant regulatory authorities and development of regulatory submissions in these areas.
Toxicology specialist guidance, nonclinical safety project design and study monitoring. RISE has gathered the expertise in-house required to allow full responsibility for toxicity and safety studies to be taken. Our experts can guide you through all necessary and scientifically important tests which are relevant for your project. In an initial discussion with our toxicologists, you will get support in planning, anticipation and aversion of potential risks. Taking early advice from a safety perspective for substances in therapeutic development, or chemicals, cosmetics, food additives and medical devices, is a wise choice on the path to “safe by design”.
Toxicological tests. We employ large in silico, in vitro and in vivo model tool-boxes, as well as relevant biological materials (eg plasma, serum, blood and tissues), to predict, identify and quantify pharmaceutical and chemical toxicity.
Studies in compliance with GLP conditions. We design and monitor animal studies according to both GLP and non-GLP standards. We can conduct animal studies in rodents and rabbits in our own facility at RISE. Our competence and capability in performing respiratory non-clinical toxicity studies is seldom encountered outside of large CROs.
Regulatory risk assessments. We put regulatory safety requirements at the centre from the onset of assessing risks of your substance/product. This may apply to pharmaceutical substances under non-clinical development, chemicals in consumer products and medical devices. We also have extensive experience in documentation of toxicological data, interpretations and conclusions and can help you to meet regulatory requirements for, amongst other things, first into human transition in pharmaceutical development.
Biocompatibility and toxicological assessments (medical devices). We can help you establish and review your biological evaluation plan for medical devices, according to ISO 10993 and ISO 14971, or other relevant standards. In addition, we can perform the required tests and evaluations necessary for toxicological and biological risk assessment reports on your medical device. Our toxicologists will give you advice, guidance and interpretation of the results.
ADME and pharmacokinetics (PK). In silico, in vitro and in vivo kinetics studies are performed to optimize the absorption, distribution, metabolism and excretion of your molecule in the discovery phase of drug development. These so-called ADME studies are crucial for understanding whether a drug candidate has the prerequisite to reach the target in the body in a proper concentration and there give the desired pharmacological effect. The results provide a good basis for planning effect and toxicological studies, as well as for toxicokinetic (TK) analyses.
Bioanalysis. With our high-resolution analysis instruments, we perform quantitative and qualitative analyses in biological materials, in wastewater and in any other matrix you may require. We measure and quantify pharmaceutical substances (APIs), chemicals, narcotics, metabolites, viruses and other biological entities. Our methods are well established and are developed in our sophisticated analytical instrument facility. We perform your analyses based on the validation needs you require, including those needed to meet the regulatory requirements for bioanalytical testing (for example GLP).
Protein analysis. Protein analyses are performed in our laboratories using, among other things, state of the art mass spectrometric, chromatographic and electrophoretic techniques. We perform qualitative and quantitative analyses to characterize proteins for a broad spectrum of customers working in Life Science. Knowing the properties of your protein is an advantage if your project or idea is in its development phase.
Lectures and training. Our qualifications, working techniques and innovations in animal welfare are world-leading. We are happy to share our knowledge in 3R and animal welfare with you and your colleagues. Also, we offer tailor-made lectures in general toxicology, risk assessment and all other specialist areas of ours.
We offer complete safety solutions for bringing new drugs and chemicals to the market. Our cross-functional project teams ensure that the right studies are coordinated into the right track for your project, using cutting edge technical approaches and highest quality standards normally found in larger pharmaceutical companies. If you need support in adjacent areas or use the same type of instrument or methodology for other purposes, please feel free to contact us for a discussion.
After an initial inquiry, we make sure that you get in touch with the expert of your specific area of interest.
Preclinical safety and anaysis services at RISE_0.pdf (pdf, 339.02 KB)