Toxicology Services for Safety and Risk Assessment
Talk to our experts for advice on planning, preparing, monitoring, and reviewing toxicology and safety pharmacology studies for your drug development.
Navigating Toxicology and Safety Pharmacology in Drug Development
Toxicology, toxicokinetics, and safety pharmacology in drug development involve evaluating the possible adverse effects of a potential drug candidate and the systemic exposure at which such effects occur. This data is used to ensure that volunteers in clinical trials are not exposed to unnecessary risks.
The experienced toxicologists at Cytel can lead you through the authority requirements and guidelines on the path to clinical trials, marketing submission, and authorization. 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.
Contact usToxicological safety assessments
Evaluate potential adverse effects and systemic exposures of your drug candidates to extrapolate relevance and ensure safety for clinical use.
Guidance through regulatory pathways
Our experienced toxicologists guide you through the requirements and regulations essential for clinical trials, marketing submissions, and approval processes.
Comprehensive toxicology services
We help you develop optimal study packages, monitor toxicity and safety pharmacology studies, and contribute to risk assessments and regulatory documentation for marketing approval.
Efficient risk management
Detailed assessment of toxicological findings by Cytel experts ensures that potential issues are contextualized, saving you time and resources, and allowing your projects to advance seamlessly.
Comprehensive Toxicological Scientific and Regulatory Support
We tailor our comprehensive toxicological scientific and regulatory support to your drug development needs. Our team can assist in preparing and reviewing toxicology project plans and strategies, ensuring they align with other critical aspects of your project such as Chemistry, Manufacturing, and Controls (CMC) and clinical development. We also perform due diligence reviews of nonclinical documents and identify gaps within your existing toxicological package.
Our experienced toxicologists actively support and engage in regulatory interactions, including scientific advice meetings with authorities, and contribute to key documents required for your regulatory submissions. Additionally, we generate crucial safety evaluation and risk assessment documents for drug components, impurities, and other relevant drug development concerns.
From Study Design to Data Evaluation
Our toxicologists will support you in 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 actively participate as study monitors in implementing, conducting, evaluating, and reporting toxicity and safety pharmacology studies. This includes studies within the Good Laboratory Practice (GLP) framework and non-GLP preliminary, dose range finding, or exploratory studies.
Our experts will also actively extract, evaluate, and summarize the data relevant to the clinical setting from each report and, equally important, justify which data is not needed.
The Road to First-in-Human Trials: Insights from a Real-World Example
In this webinar, co-hosted by our client Dicot AB, we explore their path to the first-in-human trial. We discuss navigating drug development, regulatory strategy and decision-making, authority communication, and adhering to regulatory guidelines.
Watch Webinar
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