About the practice
Regulatory expertise built over a decade.
Hughes Veterinary Consulting was founded to give small pharmaceutical companies access to the caliber of regulatory guidance typically available only to large organizations.
About the consultant
With more than 10 years of experience in veterinary pharmaceutical regulation, Dr. Hughes has guided programs through the FDA approval process from regulatory strategy, requesting sponsor fee waivers, designing pilot and pivotal clinical studies, preparing and submitting INAD technical sections, and interfacing with the FDA/CVM on behalf of the drug sponosr.
Prior to founding Hughes Veterinary Consulting, Dr. Hughes a variety of clinical development and regulatory affairs positions at both large animal health companies and early-stage biotechnology firms, developing a practical understanding of the resource constraints and strategic pressures that small companies face.
The practice focuses primarily on veterinary pharmaceuticals for companion animals and horses — dogs, cats, and equines — where deep species-specific regulatory knowledge makes a measurable difference in program outcomes.
At a glance
- Experience10+ years in veterinary pharmaceutical regulation
- JurisdictionsUS (FDA/CVM)
- SpeciesDogs, cats, and horses
- ClientsSmall pharmaceutical companies and early-stage biotechs
- Engagement modelProject-based and ongoing advisory retainers
How we work
Focused scope
We work exclusively in veterinary pharmaceuticals that fall under the jurisdiction of the FDA/CVM.
Practical guidance
Regulatory advice is only useful if it's actionable. We translate agency requirements into concrete next steps, with clear priorities and realistic timelines.
Right-sized engagement
Small companies don't need a large consulting firm. We provide senior-level expertise without the overhead — project-based or retainer arrangements to fit your stage and budget.
Ready to discuss your program?
We work with companies at every stage — from pre-INAD planning to the final NADA. Reach out to schedule an initial conversation.