Сòòò½APP

Сòòò½APP’s expert scientists blend in-depth scientific expertise and extensive capabilities to help effectively guide your animal health and veterinary products, including animal drugs, medicated food and insecticides, through the development life cycle. Our laboratory tests animal drug products, and we do not perform testing on any animals.

Our strategic, wide-ranging technical and regulatory support can help you develop and bring safe and efficacious animal health drugs, medicated feeds and more to market swiftly. Manufacturing food and drugs intended for consumption by animals in the United States faces a unique set of regulatory guidelines and challenges. Depending on the product being developed, different regulatory agencies may be responsible for applicable standards and guidance, including the Center for Veterinary Medicine (CVM) division of the FDA and the Environmental Protection Agency (EPA). Confidently navigate regulatory processes and submissions, ensuring compliance to regulations specific to the animal health industry with our comprehensive service offerings that include analytical method development and validation, testing and characterization, stability studies and stability programs, and packaging compatibility.

Animal drug regulations

The Center for Veterinary Medicine (CVM) in the FDA regulates all animal drugs, and while the regulatory guidance for animal drug development is similar to those for human drug development, there are several critical differences, including:

• Due to animal toxicology, experimental animal drug products go directly from the lab into the target animal species, and drug products for the clinic must be developed by the formulation laboratory without the extended timelines associated with human drugs
• A single pivotal clinical trial needs to be performed, though smaller trials are typically conducted prior, and unlike human drugs, there is no Phase I, II, III process with submissions and approvals
• Generic animal drug formulations do not need to match the innovator’s formulation, which is different from generic human drug development, as the Hatch-Waxman Act applies only to human drugs, thus a clinical trial must be conducted for all follow-on animal drug products

Animal feed regulations

It is important that animal health companies work with a trusted partner with experience in and knowledge of animal drug, medicated feeds, and insecticide development to reduce time-to-market. Combinations of FDA-approved drugs and food, known as medicated feeds, are a class of animal feed products which are held to the same standards of safety and efficacy as animal drug products, with an additional requirement to ensure safety of the human food chain. If livestock are treated with medicated feed, assurances must be provided to demonstrate the residues of the drug substances are below the no-effect limit in the eggs, milk and meat that enter the human food chain, which can be provided with residuals and clearance assays. Ensure animal feed products meet CVM’s requirements of pure and wholesome products that are free from harmful substances, labeled appropriately and truthfully, and produced under clean conditions with Сòòò½APP’s complete suite of animal health testing services.

EPA-regulated animal health products

Many animal products the public perceives as drugs are not regulated by the FDA. For example, flea and tick products are regulated by the EPA under the Office of Pesticide Programs (OPP), as they are considered insecticides. To comply with EPA regulations, chemistry testing per EPA Series 830 is required during the development of any new flea and tick products. Сòòò½APP’s teams of consultative regulatory and industry experts are well-versed in animal health regulations, including EPA guidance specific to animal health products, and our scientific acumen and regulatory insights can be applied to a wide range of analytical challenges faced in the animal health industry.

Animal health testing services

• Analytical method development, validation, and transfer
• Quality control
• Stability programs
• 830 series pesticide registration testing
• Packaging compatibility
• Impurities characterization
• Regulatory support
• Clinical trial materials manufacturing
• Product, lot, and batch release testing
• Preformulation
• Product formulation and process development

The Сòòò½APP advantage

Сòòò½APP delivers in-depth technical and regulatory support for a diverse range of companies and organizations serving the animal health industry. Prove the safety of ingredients for animal consumption, demonstrating that they are free from harmful substances, ensure production and manufacturing processes are performed to appropriate protocols in sanitary facilities, and make certain product labeling is compliant with specific state regulations, based on the markets that you intend to enter. Сòòò½APP’s fully customizable, comprehensive programs incorporate assays, methods and advanced instrumentation tailored to address the regulatory and industry expectations of your end market, securing your competitive advantage in the animal health market.

To learn more about our animal health product testing services, or to speak with one of our experts, contact us today.