Do you have a promising drug candidate? To optimize the success of your project it is crucial to involve toxicological expertise early on. To achieve this, we can help you compose an optimal study package, monitor your toxicity and safety pharmacology studies, evaluate the results and contribute to overall risk assessment and regulatory documents throughout the development process up to marketing approval and beyond.
A proper risk assessment of the findings in each development phase saves time and resources. In the right context and assessed by the right experts, a toxicological finding does not necessarily pose an obstacle for the project to proceed into the next phase of development.
Toxicological scientific and regulatory support
- We can help in the preparation and review of toxicology project plans and strategies, perform a due diligence review of nonclinical documents, and/or identify any gaps in an existing toxicological package. Both the timing and content of such strategies will be related to other aspects of the project, such as CMC and clinical development.
- Our toxicologists regularly support and partake in contacts with regulatory authorities, for example in connection with Scientific Advice interactions and by authoring/contributing to documents for regulatory submission.
- We also generate safety evaluation and risk assessment documents concerning various drug components or impurities and diverse other issues related to drug development.
Toxicology and safety pharmacology studies
- Our toxicologists will support the selection of an appropriate CRO for the study/studies in question, the study design, route and method of administration, selection of appropriate species, dose levels and formulations and preparation of study protocols/plans.
- We can also take an active role as Study Monitor in the implementation, conduct, evaluation and reporting of toxicity and safety pharmacology studies. This includes studies within the Good Laboratory Practice (GLP) framework as well as non-GLP preliminary, dose range finding or exploratory studies.
- We will also take an active part in extracting, evaluating and summarising the data that are relevant for the clinical setting from each report and equally important, justifying which findings are not.
How to begin? A first meeting is a good start 👇