Woods Consulting, LLC can assist clients in the development of various veterinary products.
One of the first steps in developing a veterinary product or technology for the animal health market is to establish which agency will have regulatory jurisdiction and the requirements for approval, sale and distribution. The majority of veterinary products are regulated under the Federal Food, Drug and Cosmetic Act (FDCA) which is enforced by the Food and Drug Administration-Center for Veterinary Medicine (FDA-CVM); or under the Virus, Serum and Toxin Act (VSTA) which is enforced by the United States Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS).
Veterinary product developers should also be aware of any import or export requirements before shipping product into or out the United States.
Woods Consulting, LLC has experience and expertise with regulations, veterinary clinical research and development of:
Our veterinary consultants can provide guidance on the veterinary and animal health regulatory and product development pathways. Routinely, this consists of:
- Determining if the product will be regulated as a veterinary drug, veterinary biologic, veterinary supplement, or veterinary medical device based on its mechanisms of action and intended use, as well as how the veterinary product is labeled; then
- Based on the type of veterinary product, our animal health consultants can determine which regulatory agency (US, Canada, Europe, etc.) has purview and the development requirements to enter the veterinary market.
Veterinary Product Regulations (links)
Food and Drug Administration – Center for Veterinary Medicine :The FDA-CVM regulates animal drugs and feeds and has regulatory discretion over animal medical devices and supplements.
United States Department of Agriculture – Center for Veterinary Biologics: The USDA-CVB regulates veterinary biologics which inlcude veterinary vaccines, immune modulators, and certain veterinary diagnostic products.