Veterinary Regulatory Consulting
Regulatory support for animal drug developers.
Hughes Veterinary Consulting guides small pharmaceutical companies through FDA requirements — from first concept to approved label.
What we do
End-to-end regulatory support
We work with companies developing new drugs for dogs, cats, and horses — providing the strategic and technical guidance needed to navigate the FDA approval process.
FDA/CVM Submissions
Preparation and review of INAD and NADA submissions to FDA's Center for Veterinary Medicine, including technical sections and cover letters.
Biologics Guidance - FDA or USDA Jurisdiction
Advise if a biologic product is likely to be administered by the FDA or the USDA and help write a letter requesting a determination of which agency has jurisdiction. See Biologics page.
NADA & MUMS Guidance
Specialized support for Minor Use and Minor Species designations, including eligibility assessment and application preparation.
Clinical Study Design
Protocol development for target animal safety and effectiveness studies that meet FDA evidentiary standards.
Labeling & CMC Review
Review and preparation of product labeling, chemistry, manufacturing, and controls sections to meet regulatory requirements.
Pre-submission Meetings
Preparation and facilitation of pre-INAD meetings with FDA.
About the practice
A decade of regulatory experience
Hughes Veterinary Consulting was founded to give small pharmaceutical companies access to the same caliber of regulatory expertise typically reserved for large organizations. We understand the resource constraints of early-stage companies and provide focused, practical guidance — not generic advice.
Ready to move your program forward?
Whether you're filing your first INAD or preparing a full NADA, we can help you build a clear regulatory path. Reach out to discuss your program.