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Animal Health Consulting Services

Give your product a competitive advantage with expert veterinary product development and regulatory affairs consulting services

Our animal health experts partner with sponsors and the FDA’s Center for Veterinary Medicine (CVM) to develop safe and effective animal health products. We assist clients with the product development and regulatory application processes, as well as meet with the CVM to promote efficient approval with minimal risk.

Animal health services

Our veterinary product consulting team works closely with cross-functional teams across our organization, including clinical; nonclinical; chemistry, manufacturing and controls; and publishing, to prepare regulatory documents in an electronic-submission-ready format. Additionally, we can help prepare sponsors for meetings with regulatory agencies.

We can help sponsors author regulatory dossiers, including components of:

  • Pre-Investigational New Animal Drug (Pre-INAD) meeting requests and meeting information packages
  • Investigational New Animal Drug (INAD) applications
  • Generic Investigational New Animal Drug (JINAD) applications
  • New Animal Drug Applications (NADAs)
  • Abbreviated New Animal Drug Applications (ANADAs)

We can assist with preparation and review of your labeling and promotional documentation, as well as help you obtain and maintain the necessary state licenses for distribution. Our team also provides lifecycle management services post-approval.

Our animal health consulting services can be provided for unapproved animal health products, as well.  Examples of these products include grooming aids, medicated grooming aids and nutritional supplements. Although these products do not undergo the regulatory approval process through the CVM, there are trade associations that aid in their regulation.

We also provide regulatory consulting services for animal health products regulated by authorities other than the CVM, including biologics (US Department of Agriculture [USDA]) and radiation-emitting devices (FDA Center for Devices and Radiological Health [CDRH]). Our animal health services can be customized to fit any development program for drug products, including Minor Use and Minor Species (MUMS) products and conditional approvals for drug products.

One Health Initiative

We focus on the strategic application of the One Health Initiative for the collaborative, efficient and cost-effective development of new drugs for animals and humans. Our regulatory experts often participate as panel speakers and thought leaders in events such as the annual One Health Summit held in Kansas City, Missouri.

Animal Health Corridor

We’re located in the Animal Health Corridor, which represents the largest concentration of animal health companies in the world and 56% of total worldwide animal health, diagnostics and pet food sales.

Holly Winchell, DVM

Holly Winchell, DVM

Principal Scientist, Regulatory Affairs and Product Development

Animal Health Product Development Services

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