s meet this standard, providing definitive safety and risk assessment data required for confident clinical translation. Our robust quality system ensures strict adherence to Good Laboratory Practice (GLP) standards to meet the stringent requirements of global regulatory agencies like the FDA. Our focus on data integrity, robust SOPs, and independent quality assurance provides an unimpeachable foundation for your regulatory submission.
BioLegacy’s extensive multi-species capacity, from rodents to non-human primates (NHP), provides the flexibility to design the most scientifically sound and translationally relevant toxicology studies. Our pharmacologically relevant species and adherence to ICH guidelines for both a rodent and non-rodent model ensures a comprehensive evaluation of your therapeutic’s safety profile. Integrating our deep toxicological expertise with this broad species flexibility, we empower our partners to make critical go/no-go decisions with confidence and accelerate their path to the clinic.
Available species include:
BioLegacy is a strategic partner in your preclinical toxicology program, providing deep scientific and regulatory expertise. Our collaborative, iterative protocol development ensures your study designs are robust, scientifically sound, and precisely aligned with your objectives. Our dynamic study management approach provides the critical flexibility to accommodate protocol amendments in response to emerging data, while our commitment to continuous communication — including regular updates and data transfers — provides you with near-real-time visibility and a comprehensive understanding of your study’s progress from initiation to final report.
A robust toxicology study is underpinned by precise and reliable analytical data. BioLegacy’s deep in-house bioanalytical capabilities are fully integrated with our toxicology services to provide a seamless data generation workflow for early-stage discovery toxicology or GLP-compliant, IND-enabling studies. Rigorously characterize and quantify drug exposure (toxicokinetics), anti-drug antibodies (immunogenicity), and key pharmacodynamic biomarkers. From gold-standard LC-MS/MS for small molecules to advanced ligand-binding assays using our Meso Scale Discovery (MSD) platform for biologics, we deliver the high-fidelity data required to accurately interpret toxicology findings and support confident decision-making.
See why BioLegacy is the preferred toxicology partner for pharmaceutical and biologics sponsors across the globe.