In the intricate world of drug development and product safety, understanding the potential general toxicological effects of substances on the human body is paramount. Our contract research organization stands as your trusted partner, offering comprehensive nonclinical general toxicology research services to understand the supra-pharmacological and toxicological intricacies of your products to safeguard human health.
With a team of scientists and toxicologists, we provide a comprehensive suite of preclinical general toxicology services, tailored to your specific needs. Our expertise encompasses:
Acute Toxicology Studies: Evaluate the immediate effects of a single dose of your test substance, providing essential data for hazard identification and data for dose selection.
Repeat Dose and Chronic Toxicology Studies: Assess the potential health effects through repeated exposures to your substance, gaining insights into potential sub-chronic and chronic toxicities and identifying potential target organ mediated effects if clinical relevances.
Genotoxicity Testing: Determine if your substance has the potential to damage DNA, a critical risk factor for cancer development. This information is essential for identifying potential mutagenic and chromosome damaging effects.
Reproductive and Developmental Toxicology: Evaluate the potential effects of your substance on fertility, pregnancy, and embryo-fetal and postnatal development, safeguarding future generations from potential adverse reproductive effects.
Toxicokinetics: Understand the absorption, distribution, metabolism, and excretion of your substance in the body, essential for predicting potential adverse effects and establishing safe exposure limits.
Safety Pharmacology: Assess potential adverse effects of your substance on major organ systems, such as the cardiovascular, respiratory, and central nervous systems, ensuring key safety endpoints for your products.
Risk Assessment and Regulatory Support: Analyze the potential risks associated with exposure to your substance and navigate the complexities of global safety testing regulations, ensuring compliance with FDA, ICH, and EMA guidance documents and facilitating smooth product approvals.
Expert Consulting: Gain insights from our experienced toxicologists, who provide expert guidance on all aspects of preclinical general toxicology study design, data interpretation, and regulatory compliance.