Company: NOTV
Filing Date: 2025-12-05
Form Type: 10-K
Source: 0001628280-25-055483
Chunk: 222

Company: Inotiv, Inc.
Filing Date: 2025-12-05
Form: 10-K
Item: Item 1
Chunk 222
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 established, in partnership with the Company, to ensure adherence to all federal Animal Welfare Act and Clean Water Act laws, rules, and regulations, as well as all federal and applicable state and local animal welfare, animal cruelty, water, and sewage laws, rules, and regulations. This also included compliance with Company policies, procedures, and the Resolution Agreement and the Plea Agreement. The compliance monitor collaborates with the Company to oversee the nationwide compliance plan (as defined in the Plea Agreement), ensuring all activities are conducted ethically and in full compliance with the established regulatory framework.

Analytical Services

Laboratories that provide information included in INDs, NDAs and BLAs must conform to regulatory requirements that are designed to ensure the quality and integrity of the testing process. Most of our contract research services are subject to government standards for laboratory practices that are embodied in regulations for GLP, CGMP, BE and GCP. The FDA, Environmental Protection Agency and other regulatory authorities require that test results submitted to such authorities be based on studies conducted in accordance with the regulations listed above. These requirements include but are not restricted to the following areas:

•Resources – organization, personnel, facilities and equipment;

•Rules – protocols and written procedures;

•Characterization – test items, test systems and method validation;

•Documentation – raw data, final report and archives; and

•Quality unit – formalized internal audit function.

We must also maintain reports for each study for specified periods for auditing by the study sponsor and by the FDA or similar regulatory authorities in other parts of the world. Regulatory monitoring authorities such as the FDA, have indicated an increased emphasis on the management of electronic records generated by computerized systems to ensure data integrity. Noncompliance with these regulations can result in the disqualification of data collected during 

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the preclinical trial, which would substantially impact our ability to meet our obligations to clients, and, in severe cases, lead to discontinuance of selected operations.

Nonclinical Services

Our animal research facilities are subject to a variety of federal and state laws and regulations, including rules and regulations enforced by the National Institutes of Health ("NIH") and the United States Department of Agriculture ("USDA"), such as the Animal Welfare Act ("AWA"). These regulations establish the standards for the humane treatment, care and handling of animals by breeders, dealers and research facilities. Our animal research facilities maintain detailed standard operating procedures and other documentation designed to comply with applicable regulations for the humane treatment of animals in our custody. If the USDA determines that our equipment,