Toxicological Risk Assessment

Toxicological risk assessment is vital in drug development because it helps you evaluate the potential hazards of your drug candidate. By identifying and mitigating risks early, you can ensure patient safety and make informed regulatory decisions, supporting the overall success of your drug development process.

What can we do for you?

Our team has over 35 years of proven expertise in toxicological risk assessment of a drug. Based on existing data from non-clinical studies, clinical trials, literature reviews, and similar compounds, we support in identifying and characterizing potential hazards of a drug. Throughout the processes of Dose-Response Assessment, Exposure Assessment, Risk Characterization, our experts ensure that the safety profile of your drug is understood.

We support in safety/risk assessments in the context of CTD module 2.4 submissions, IMPD/IND’s and for specific issues in e.g. genotoxicity, carcinogenicity.

Contact us today to discuss how our tailored approach can support your regulatory requirements and advance your research objectives. Together, let’s shape the future of safer and more effective therapies.

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Rezual Karim
RA Manager
Rezual Karim

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Rezual Karim
RA Manager

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Talk to an expert