Licensure of veterinary biologicals in the United States (US) is complex and daunting. But it doesn't have to be that way. Navigating the federal regulations and various memoranda is confusing and can lead to assumptions that are inaccurate. I am a consultant with Consultants for Veterinary Biologics, LLC, where we provide a one-stop solution to your study design (efficacy, safety, potency, diagnostic panels), statistical, and inspection and compliance needs; all of which are involved in licensure of veterinary biologicals. I provide a seamless approach to licensing veterinary biologicals in the US specific for your product. This applies to start-up companies (domestic and foreign) as well as established companies (domestic and foreign). While I have recently formed Veterinary Biologics Permitting Services, LLC, to fill a niche market to provide a pathway for non-US manufacturers to license (permit) their product in the U.S., I continue to be a consultant with CVB, LLC. Having the most regulatory experience (~35 years) with the Federal Agency responsible for regulating veterinary biologicals (The Center for Veterinary Biologics-APHIS-USDA), of all of our consultants, my experience enables me to make the licensure/permitting process for veterinary biologicals be as seamless as possible. This applies to initial submissions, study protocols/final reports, study design (efficacy, safety, potency, validation) of all product types for start-up and established companies (domestic and foreign) seeking to license their veterinary biologic in the United States. I have licensed/permitted hundreds of product types (vaccines, immunotherapies, cancer, diagnostics, allergenics, antivenin, etc) prior to retirement in July 2021. Some products (new technologies) did not conform to existing policies/guidelines. Over the years, I have also interacted with several international regulatory authorities. My approach to consulting new firms is simple: to teach companies how to license/permit their product in the US. Licensure is a process that can be confusing and daunting. I will provide you with a general overview of the processes/regulations (if needed) and provide guidance tailored to your specific product. I am also able to interact with the regulatory agency on your behalf if needed. If I can be of assistance to your firm, don't hesitate to contact me at kevinruby@cvbllcusa.com and I will be your primary contact. Additional information provided on our website at consultantsforveterinarybiologics.com
