FDA Application and GMP Consulting
Animal Feed and Drugs
Animal and Pet Food
Animal and pet food refers to a ny product that is
intended to be used as animal feed ingredient, to become part of a feed
ingredient, or added to an animal's drinking water.
FDA Application for New Animal Drug
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Safety and effectiveness for target food and non-food animals
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Safety for human consumption of drug residue in treated food animals
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Environmental impact
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Manufacturing methods and procedures (chemistry)
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GMP, GLP, and GCP compliance
FDA Application for Feed Additives
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Human food safety
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Target animal safety
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Manufacturing chemistry
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Utility (intended physical, nutritional or other technical effect)
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Environmental impact
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Labeling (cautions, warnings, shelf life, directions for use)
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Necessary health claims
FDA Application for Animal Drug
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Investigational New Animal Drug exemption (INAD)
Data regarding safety for human consumption
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New Animal Drug Application (NADA)
Data regarding safety and effectiveness for targeted animals as well as safety for human consumption
Services
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Conducting GLP, GCP, and GMP auditing according to U.S. FDA抯 requirements
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Assisting feed safety analysis
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Preparing FAP and submitting to the U.S. FDA
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Assisting safety analysis of new animal drugs
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Preparing experimental protocols for safety and efficacy analyses of new animal drugs
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Preparing INAD and NADA package as well as submitting to FDA
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Meeting and corresponding with the U.S. FDA
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Applying medicated feed mill licensing from the U.S. FDA
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Acting as the U.S. agent for registration of food facilities
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Identifying clients in need of animal/pet foods and drugs