Inotiv

Inotiv delivers a broad array of nonclinical and analytical services from discovery through clinical development, and provides the broadest range of research models and related services to pharmaceutical and biotech companies, government and academia. Its work centers on toxicology, in vivo pharmacology and disease models, research animal and transgenic models, and bioanalysis.

Toxicology and Safety Assessment

• Assess nonclinical safety with GLP toxicology, acute and repeat-dose toxicity, carcinogenicity, developmental and reproductive toxicology, juvenile animal studies, and safety pharmacology covering respiratory, CNS, and cardiovascular studies.
• Prepare IND-enabling nonclinical support through study execution and reporting, including nonclinical pharmacology summaries and regulatory-compliant data packages.

Pharmacology and Research Models

• Evaluate efficacy, disease biology, and mechanism of action through in vivo pharmacology and disease models across multiple therapeutic and disease indications. Inotiv also produces custom antibodies, from in vivo and in vitro production to hybridoma development.
• Source and develop research animal models, including surgically modified models, contract breeding, and genetically engineered rodents customized through gene deletion, insertion, and other modifications. Its models are raised on Teklad diet, bedding and enrichment, and LabTracks gives clients access to the system that manages their colonies.

Bioanalysis, DMPK and Translational Studies

• Generate bioanalytical and biomarker data through bioanalytical method development and validation, biomarker analysis of preclinical and clinical samples, and interpretation of results.
• Characterize drug metabolism, pharmacokinetics, ADME, DDI and transporter behavior using in vitro assays, PK-TK analysis, and related bioanalytical methods; clinical teams can also use regulated clinical bioanalysis for PK/PD sample analysis and bioequivalence programs.

Pathology, Devices and Submission Data

• Analyze tissues and samples through histology, immunohistochemistry, immunofluorescence, specialized pathology, proteomic quantification with its Target Sufficiency platform, and clinical pathology for animal and preclinical studies.
• Support medical-device development with biocompatibility testing, device toxicology studies and device pathology, and prepare CDISC-compliant SEND packages containing XPT datasets, define.xml, a stylesheet, and an nSDRG.

Best Fit

• Best suited to pharmaceutical and biotechnology teams seeking CRO and laboratory support for preclinical safety, pharmacology, research models, bioanalysis, DMPK, pathology, and selected regulatory data deliverables.