Regulatory Pathology

Our histopathology team provides expert contract histologic slide preparation and regulatory pathology evaluation of tissues from both supporting GLP and non-GLP toxicology studies, pharmacology and efficacy studies, basic research and diagnostics. Our clients include pharmaceutical and biotechnology companies, universities, NIH/NIEHS/NPT, and other federal grant funded organizations, hospitals, US Military and basic researchers.

For preparation of histology and pathology studies for regulatory submission, CBI follows FDA, OECD, EPA, STP, NTP, MHW, FISA and EMEA guidelines for preparation of tissues for histopathologic examination. Our professional staff is experienced and capable in both slide preparation and pathologic evaluation in all relevant species.

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Capabilities

  • 1-, 3-, 6- and 12-month studies in all species
  • Chronic and carcinogenicity studies
  • Exotics
  • Immunohistochemistry, in situ hybridization and special histochemical stains
  • Short- and long-term device studies, including plastic and grinding studies
  • Single dose and acute range finding studies
  • Tissue cross reactivity studies

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