Business: Veterinary market analysis, financial modeling and licensing strategies
Regulatory: Investigational New Animal Drug Applications (INAD), Veterinary Master Files (VMF), Outlines of Production
Clinical: Protocol development and veterinary clinical study documentation for veterinary drugs, biologics, diagnostics, and devices
About our veterinary consultants
Since 2007 our veterinary consultants have provided comprehensive guidance to human and animal health companies. Our expertise spans animal health regulations, veterinary clinical research, product development, and developing strategies for entering the animal health market including collaborations with veterinary distributors and veterinary companies. Our animal health consultants have decades of real-world, hands-on experience in clinical practice, industry, and academia as well as starting our own veterinary companies and serving as investigators on dozens of veterinary clinical studies.
Our animal health consultants work with early to late stage veterinary companies, veterinary laboratories, medical device companies, veterinary contract research organizations, animal health investors, market research firms as well as human biomedical companies seeking to enter the animal health market or leveraging veterinary clinical studies to obtain real-world data in comparative diseases. We can also work with established animal health companies seeking to license or acquire technologies from the human pharmaceutical sector.
Our veterinary consultants services
Animal health products in the US fall under the oversight of the FDA Center for Veterinary Medicine, USDA Center for Veterinary Biologics or the Environmental Protection Agency. Animal health product purview largely depends on its intended use and mechanism of action, and each agency has different requirements for research and development of animal health products.
01Veterinary Business Development
veterinary market analysis & forecasting, research and development plans, budgets, commercialization plans, and veterinary product licensing strategies for animal health products.
02Veterinary Clinical Studies
veterinary clinical study protocols and study documentation, guidance on veterinary clinical study compliance for veterinary drugs, biologics, etc.
03Veterinary Regulatory Guidance
veterinary regulatory guidance (21 CFR, 9 CFR) and submissions for veterinary pharmaceuticals, devices, diagnostics & biologics.
Clinical research veterinarians advancing comparative medicine and translational research
Existing Challenges in Drug Development: The majority of in vivo pre-clinical research is performed in artificial environments using laboratory animal models with low phenotypic diversity and induced disease states. Although these models can provide insight into disease mechanisms, they consistently fail in predicting human safety and efficacy and has prompted the US Food and Drug Administration’s to explore solutions (see “Advancing New Alternative Methodologies at FDA“).
Comparative Medicine (One Medicine): Comparative medicine evaluates similarities among animal species to enhance the understanding of mechanisms of human and animal disease and facilitates the translation of basic science knowledge into clinical applications. Our veterinary consultants focus on comparative medicine and veterinary clinical studies to leverage the sophistication of veterinary medicine and naturally occurring veterinary diseases which share molecular, cellular, physiological and clinical disease homology to humans. Veterinary clinical studies provide our companion pets access to novel therapeutics and diagnostics that may be otherwise unavailable, while gathering valuable information to advance human and veterinary pharmaceuticals.
Principal Veterinary Consultant
Craig Woods DVM, MS, MBA (Owner: Woods Consulting, LLC)
Craig Woods has served as the principal veterinary consultant of Woods Consulting, LLC (fka Animal Health Consulting) since 2007. Craig is a licensed veterinarian in the State of Arizona and is the Director of Infectious Disease and Biosecurity Projects at the Institute for Future Health, a joint venture between Arizona State University and the University of Arizona. Prior to academia, he spent >15 years in industry, holding clinical, regulatory and business development positions. Craig has directed and served as investigator on human and veterinary clinical research studies in toxinology, orthopedics, oncology, infectious disease, ophthalmology and cardiology.
Education / License
BS (1991) University of Missouri
MS (1995) University of Missouri
DVM (1995) University of Missouri
MBA (2003) Arizona State University
AZ Veterinary Medical License
(1995-current)
additional information from our veterinary consultants
veterinary market – animal health market
Sales: global ex-manufacturer sales of animal health products: $33B USD
Region: 33% US and 30% Europe
Products: 60% pharmaceuticals, 30% biologics, 10% medicated feeds.
Species: 60% livestock, 40% companion animal
Veterinary Company Types: Veterinary manufacturers, veterinary distributors, veterinary reference laboratories, and veterinary corporate hospitals.
veterinary regulations – updates and links
FDA-Center for Veterinary Medicine Updates
USDA-Center for Veterinary Biologics (CVB)
animal health events
Animal Health Annual Summit (Aug. 26-27, 2024.): An ideal summit to learn about emerging veterinary companies and learn from experts in the animal health industry. Attendees include representatives from veterinary distributors, start-up and mature animal health companies, animal health investors, veterinary contract research organizations and others. LINK
Comparative Medicine Symposium (Nov. 30, 2023; Scottsdale, AZ.): Dr. Woods organized the first ASU Comparative Medicine Symposium to discuss veterinary medicine’s role in transforming translational research. Speakers from ASU, NAU, UA, TGen North, industry and private practice discussed contemporary animal health topics including innovations in veterinary oncology, cardiology, infectious disease, canine aging and veterinary clinical research to over 130 veterinarians, physicians, and researchers from across the State of Arizona. Speakers: Bridget Barker PhD; Emily Bray PhD; Evan MacLean PhD; Matthew Miller DVM, MS, DACVIM (cardiology); George Poste DVM, PhD, DSc; Noah Snyder-Mackler PhD; Rachel Venable DVM, MS, DACVIM (oncology); Craig Woods DVM, MS, MBA; and Hayley Yaglom MS, MPH.
