Genesis Global Group
Genesis Drug Discovery & Development
GD3

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Genesis Drug Discovery & Development is a proud member of Genesis Drug Discovery & Development (GD3), a fully integrated CRO providing services to support drug discovery programs of our clients from target discovery through IND filing and managing Phase I-III clinical trials.

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Disease Modeling

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GLP and Non-GLP Toxicology

Early toxicity identification in non-GLP in vivo safety studies allows better utilization of resources in more costly and time-consuming regulatory toxicology studies. In addition, the information from the discovery safety experiments triggers early mechanistic efforts to understand the toxicity's nature and select the most viable development candidates or make an early no-go decision for the target.

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Non-GLP discovery toxicology and animal clinical pathology services include:

  • Test Agent Administration
    • Oral Gavage
    • Intravenous
    • Intra-peritoneal
    • Intra-tumor
    • Intra-tracheal
    • Intra-nasal
  • Body weight measurements
  • Serum and urine clinical chemistries
  • Hematological analysis of peripheral blood
  • Immuno-phenotyping of peripheral blood and tissues by fluorescence-activated cell sorting (FACS)
  • Tissue collection and processing for histological analysis
  • Phenotypic characterization of genetically modified mice for target liability assessment
  • Toxicity evaluation in knock-out mouse models

GLP toxicology services can also be provided

  • Species
    • Mouse
    • Rat
    • Dog
    • Minipig

Offerings available in GLP or non-GLP compliance depending on your study needs and budget

Whether you are looking for general non-GLP in vivo testing to help accelerate program viability decisions or need GLP-compliant testing for IND submissions, GD3 provides customized services that meet your study needs and budget. Speak with our team of experts, who can evaluate your needs and properly determine which route is appropriate to save you both time and money.

A good GLP Program typically includes several key elements, including:

  • Standard Operating Procedures
  • Comprehensive personnel training
  • Consistency
  • Accountability
  • Study documentation
  • Quality Assurance (QA) oversight and auditing
  • Facilities and instrumentation maintenance and validation