Toxicology and Regulatory Studies

The Histopathology Laboratory at CBI a provides expert contract histologic slide preparation and evaluation of tissues from both animal and human tissues supporting GLP and NonGLP 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, 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 animal species.

• Single dose and acute range finding studies in all species
• 1, 3, 6, 12 month studies in all species
• Carcinogenicity Studies
• Short and Long Term Device Studies – including plastic and grinding studies
• Veterinary species – sheep, goats, pigs, horses, cattle
• Fish including Zebra Fish and Environmental Studies
• Tissue Cross Reactivity Studies
• Immunohistochemistry, In Situ hybridization, and special histochemical stains
• Studies include slide preparation, 100% QC and slide to block match, critical phase audits by CBI QAU, boxing and shipping of slides, blocks and wet tissues, preparation of wet tissues for long term archiving, complete study report if pathologic examination is conducted, and compliance statements.