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