Preclinical Development

Safety & Toxicology

Integrated preclinical safety and toxicology assessment center.

  • Toxicology

    We provide an array of services for investigational purposes, or IND, support. Typically, GLP toxicology, GLP toxicity studies, and pivotal toxicity studies are performed in two species for durations of 14 or 28 days, and often include translational biomarkers or investigational endpoints that assist with compound development.

    Toxicity studies are complemented by safety pharmacology studies, commonly conducted simultaneously to expedite development. All standard dosing regimens and species are supported, including primates, and our GLP tox studies are conducted in strict compliance with GLP regulations. Our GLP toxicology studies have supported hundreds of successful client IND submissions.

  • Pivotal Toxicology

    We offer pivotal toxicology studies for safety toxicity and toxicity evaluation of candidate compounds. Our toxicological studies are conducted on a variety of animal models, ranging from IND-enabling to smaller tox studies, and provide a basis for identifying hazards and conducting safety assessments that support IND filing and support use in humans. Our IND-enabling toxicology is performed by experienced scientists who can recommend appropriate study parameters and protocol elements, enabling the collection of a robust and comprehensive data package for IND submission. We offer comprehensive expertise to execute your IND study needs with services optimized to meet the most aggressive execution timelines.

Safety and Toxicology Assessment

Pre IND Application

  • Dose Range Finding Test
  • Single-dose & Repeated-dose Toxicity Testing
  • Genotoxicity
  • Safety Pharmacology
  • Local Toxicity Testing
  • Immunogenicity Testing
  • Toxicokinetics (TK)

Post IND Service

  • Chronic Toxicity
  • Juvenile Toxicological Study
  • Carcinogenicity Study
  • Developmental and Reproductive Toxicity Study (DART)

GLP analysis support

  • Formulation Method Development, Validation, and Analysis under GLP Conditions
  • Biological Samples Analysis Methodology Development and Validation under GLP conditions

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