United Pharmaceuticals Inc. delivers comprehensive preclinical toxicology programs designed to establish safety, support regulatory compliance, and advance drug candidates with confidence. Backed by deep scientific expertise and advanced infrastructure, our toxicology studies generate high-quality data required for critical development milestones, including first-in-human clinical trials.
Our integrated approach ensures that safety risks are identified early, interpreted accurately, and addressed strategically—helping sponsors move forward efficiently while meeting global regulatory expectations.
We conduct both good laboratory practice and non-good laboratory practice studies in rodent and non-rodent species to support safety evaluations for healthy volunteers, patient populations, and special clinical groups.
Each study is designed with scientific rigor and regulatory alignment in mind, ensuring data relevance for investigational new drug submissions and beyond. Our teams are available to discuss your program goals and help tailor toxicology strategies that align with your compound profile and development timeline.
United Pharmaceuticals Inc. operates Association for Assessment and Accreditation of Laboratory Animal Care International–accredited facilities capable of housing diverse species in custom-designed environments. Our in-house bioanalytical laboratories and strict adherence to good laboratory practices ensure studies meet international regulatory standards.
Our toxicology protocols are recognized by regulatory agencies across North America, Europe, and Japan, supporting clinical development programs across a broad range of therapeutic indications and patient populations.
Early-stage toxicity and carcinogenicity studies are conducted in full compliance with good laboratory practices. We generate Standard for Exchange of Nonclinical Data–ready datasets to support seamless global submissions. All study designs align with country-specific regulatory requirements for clinical testing and commercialization.
Our network of modern preclinical facilities provides the scale and flexibility required for complex toxicology programs, including:
Our pivotal toxicology studies span durations from acute exposure through long-term evaluations of up to two years. Study designs are customized based on compound characteristics, intended clinical use, and regulatory requirements.
To ensure comprehensive study execution, we provide in-house support across key scientific disciplines, including formulation development, analytical chemistry, and dose formulation analysis, bioanalysis, pharmacokinetic and toxicokinetic data interpretation, and clinical pathology. Additional capabilities include flow cytometry, cytokine and biomarker analysis, polymerase chain reaction testing, anatomic pathology, immunohistochemistry, biodistribution analysis, and preparation of Standard for Exchange of Nonclinical Data–compliant datasets.
United Pharmaceuticals Inc.’s preclinical toxicology programs support a structured and data-driven approach to drug development. By identifying safety signals early and interpreting findings in a regulatory context, our studies help reduce uncertainty and minimize the risk of unexpected outcomes during later clinical stages.
Our goal is to provide clear, reliable safety data that empowers sponsors to advance their programs with confidence and clarity.