Exploratory Toxicology & Toxicology Risk Assessment
Sai Life Sciences provides exploratory toxicology and toxicology risk assessment services to deliver early safety insights and reduce the risk of costly late-stage failures. We support compound safety evaluation, dose selection, identification of target organs for toxicity, prediction of potential human risks, and strengthening of IND submissions. Working in close collaboration with chemistry, biology, DMPK, and pharmacology teams, we ensure toxicology decisions are grounded in robust science and aligned with program objectives. We also provide toxicology risk assessment (TRA) services, including PDE (Permitted Daily Exposure) and OEL (Occupational Exposure Limit) establishment, to support compliance with global health-based exposure limits and workplace safety standards.
Our Capabilities
Discovery Toxicology
Early in vitro and in vivo screening to identify potential safety liabilities before scale-up.
Genotoxicity assessment
Tiered evaluation to identify potential DNA-damaging properties of compounds or mixtures early in development.
Dose Range Finding & Repeat Dose Studies
Studies to define safe exposure levels and establish therapeutic windows.
Integrated toxicology insights
Toxicology programs embedded within discovery workflows for faster, data-driven candidate progression.
Toxicology risk assessment
Systematic evaluation of toxicological risks using predictive models, historical data, and integrated safety insights, including PDE and OEL determination.
Our Capabilities
Discovery Toxicology
Early in vitro and in vivo screening to identify potential safety liabilities before scale-up.
Genotoxicity assessment
Tiered evaluation to identify potential DNA-damaging properties of compounds or mixtures early in development.
Dose Range Finding & Repeat Dose Studies
Studies to define safe exposure levels and establish therapeutic windows.
Integrated toxicology insights
Toxicology programs embedded within discovery workflows for faster, data-driven candidate progression.
Toxicology risk assessment
Systematic evaluation of toxicological risks using predictive models, historical data, and integrated safety insights, including PDE and OEL determination.
Facilities, Equipment, and Technical Capabilities
Our toxicology facilities provide dedicated infrastructure for both in vitro and in vivo studies, supporting acute, sub-chronic, genetic, and mechanistic evaluations for comprehensive safety assessment. Advanced analytical, histopathology, and biomarker capabilities enable generation of high-quality safety data aligned with global regulatory expectations and support early, informed decision-making across discovery and preclinical development.
Frequently Asked Questions
Yes. Sai Life Sciences provides both in vitro and in vivo toxicology services as part of its integrated drug discovery offerings. Our facilities support non-GLP toxicology studies in rodents and non-rodents (with third-party support), including tolerability, dose range finding, repeat-dose studies, toxicokinetics, and pathology services, with oral, intravenous, and dermal routes of administration.
These studies are conducted under strict ethical and regulatory standards to support early-stage decision-making and safer candidate selection.
Yes. We support IND-enabling exploratory toxicology studies as part of our integrated discovery services. Our facilities operate with relevant ethical and animal research accreditations, enabling high-quality study execution and streamlined transition toward clinical development.
Yes. We provide comprehensive genotoxicity and mutagenicity testing aligned with ICH-M7 guidelines. Capabilities include in silico and in vitro evaluations of starting materials, intermediates, and APIs, as well as non-GLP studies such as the Ames test (micro, mini, and full), in vitro chromosome aberration assay, and in vitro micronucleus test.
These services support regulatory submissions and impurity risk assessments throughout development.
Yes. Our pathology laboratory supports hematology, coagulation, clinical chemistry, electrolytes, urinalysis, necropsy with organ collection and weighing, histopathology, immunohistochemistry, and digital pathology workflows.
The facility is equipped with advanced staining, slide scanning, and microscopy systems to support accurate diagnosis, high-quality data generation, and efficient study reporting.
Yes. We provide toxicology risk assessment services including PDE and OEL calculations, impurity risk evaluations, and ICH-M7-aligned assessments. These services support exposure control strategies, patient safety, manufacturing risk management, and regulatory readiness.