Company: NOTV
Filing Date: 2025-12-05
Form Type: 10-K
Source: 0001628280-25-055483
Chunk: 211

Company: Inotiv, Inc.
Filing Date: 2025-12-05
Form: 10-K
Item: Item 1
Chunk 211
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 devices as well as cardiovascular safety evaluation in radiotelemetry-implanted animals.

•Stability Testing: We test stability of nonclinical drug dosing formulations and collect bioanalysis samples designed to ensure the integrity of all solutions used in nonclinical and clinical studies and post-study analyses. 

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Table of Contents

Results from sample shipping and storage studies assist our clients in maintaining sample integrity throughout the process from collection to analysis.

•Bioanalytical Method Development and Validation: During regulatory development, bioanalytical methods are validated to an appropriately robust level to advance accuracy and reproducibility. These methods are used to quantify drug product or metabolites in biological matrices, as well as appropriate safety or efficacy biomarkers.

•Drug Metabolism, Bioanalysis, and Pharmacokinetics Testing: We analyze samples from in vitro, preclinical and clinical studies to identify and measure drug and metabolite concentrations in complex biological matrices, including drug metabolism, bioanalysis and pharmacokinetics studies.

•Archiving Services: We provide climate-controlled archiving services for our clients’ data, samples and specimens at many of our DSA facilities.

New Service Offerings

During the twelve months ended September 30, 2025, 2024 and 2023, we spent $2,282, $3,278 and $6,858, respectively, on startup costs for new service offerings that we are building internally including biotherapeutics and genetic toxicology. 

Research Models and Services

The RMS segment is comprised of (1) Research Models, (2) Diet, Bedding and Enrichment, and (3) Research Model Services.

Research Models: Our research models business is comprised of the commercial production and sale of laboratory animals and research models for use by scientific researchers, principally purpose-bred small animal models (primarily mice and rats) and large animal models (NHPs and rabbits). We provide these models to numerous clients around the world, including many academic institutions, government agencies, biopharmaceutical companies, and CROs, and we have a global footprint with production facilities strategically located in three countries.

Our research models include standard stocks and strains, immunocompromised models (which are useful for oncology research), disease models (which are in demand as early-stage research tools) and genetically-engineered models (“GEMS”) (which are often created for specific research projects). 

•Small Animal Research Models: Our rodent species have been and continue to be among the most-used research models in the world, largely as a result