Our services
Regulatory support across the full development lifecycle.
From first concept to approved label, we provide the strategic and technical guidance your program needs to move forward with confidence.
US Regulatory Pathways
FDA/CVM Submissions
Preparation and review of Investigational New Animal Drug (INAD) files and New Animal Drug Applications (NADA) to FDA's Center for Veterinary Medicine. We draft technical sections, cover letters, and responses to agency information requests.
Includes INAD establishment, technical section preparation (Target Animal Safety, Effectiveness, Human Food Safety, Environmental Impact, Manufacturing), and NADA compilation.
MUMS Guidance
Specialized support for Minor Use and Minor Species (MUMS) drug determinations and designations. We assess eligibility, prepare designation requests, and guide sponsors through the conditional approval pathway.
Covers MUMS determination and designation applications, conditional approval strategy, and the annual reports required to maintain conditional approval status.
Pre-submission Meetings
Preparation and facilitation of pre-INAD meetings and Type VII VMF meetings with FDA/CVM. We develop meeting packages, draft questions, and prepare sponsors for productive agency interactions.
Includes meeting request preparation, briefing document drafting, question development, and post-meeting follow-up action planning.
Technical & Scientific Support
Clinical and Nonclinical Studies
Protocol development for target animal safety (TAS) and effectiveness studies that meet FDA evidentiary standards. We help sponsors design studies intended to support your proposed drug indications and that generate data regulators will accept.
Includes study design, endpoint selection, statistical considerations, and Good Clinical Practice (GCP) compliance guidance for field and laboratory studies.
Educational Seminars
Dr. Hughes conducts two-day in-person seminars providing a comprehensive overview of the veterinary drug approval process. Information is available at AnimalDrugDevelopment.com
Typical group size is 8-12 people, which allows for plenty of interaction and discussions. Participants are encouraged to ask questions at any time during the presentations.
Regulatory Gap Analysis
Assessment of existing data packages against FDA requirements. We identify gaps, prioritize studies, and develop a practical plan to reach submission-ready status.
Includes data package review, gap identification, study prioritization, and timeline and budget estimation for regulatory milestones.
Not sure which services you need?
Most engagements begin with a scoping call to understand your program and identify the right regulatory path. Reach out to start the conversation.