Animal Health and
Veterinary Pharmaceutical
Consultants
clinical research, regulatory affairs and business development for
veterinary pharmaceuticals, veterinary biologics, and veterinary medical devices
About our Veterinary Consultants
Our veterinary consultants’ careers span industry, academia and clinical practice with expertise in technology assessment, veterinary clinical studies, regulatory submissions and licensing negotiations. Formed in 2007 by Craig Woods DVM, MS, MBA, our animal health consulting team has assisted dozens of biopharmaceutical companies, veterinary companies, veterinary contract research organizations, and universities advance their technologies for the animal health market. Our licensed veterinarians possess a deep understanding of veterinary regulations (FDA, USDA), design and management of veterinary clinical studies, and forming strategic partnerships with veterinary companies and veterinary distributors.
Animal Health Consulting Services
Veterinary Clinical Studies
We have extensive experience as study investigators, developing veterinary study protocols and documentation, and managing pilot and pivotal veterinary clinical trials (e.g., veterinary clinical studies). Veterinary clinical studies give pets access to new veterinary therapeutics while gathering valuable data to advance human and veterinary medicine. Dr. Woods has experience in both human and veterinary clinical research and our veterinary clinical studies are developed and performed similar to human clinical studies.
Veterinary Regulatory Consulting
Our team can support veterinary regulatory affairs and submissions for veterinary drugs (21 CFR), veterinary biologics and veterinary diagnostics (9 CFR), and other regulated veterinary products. We can assist clients in preparing and submitting product development plans, INADs, production outlines, blueprints, and other documents to the FDA-Center for Veterinary Medicine and USDA-Center for Veterinary Biologics, as well as serving as regulatory liaisons and responsible officials for third parties.
Animal Health Business Development
Our veterinary consultants can perform veterinary market research and competitive analysis, veterinary sales forecasting, and create financial models that incorporate R&D, regulatory fees and other expenditures related to veterinary product development. We can also create product development plans and commercialization strategies, and assist with veterinary company formation and interim management. Our animal health consultants have negotiated a range of agreements with veterinary companies and veterinary distributors including option, license, material transfer, and manufacturing agreements.
Veterinary Research: basic research and bioinformatics
Through our network, we can provide large scale data analysis including cleaning, biostatistics, advanced data analytics, visualization, and interactive web-based tool development using natural language processing (NLP), R, Python and other programming languages for a customized approach to analyzing large datasets. We can also support and coordinate a range of specialized testing of biospecimens including multi-omics (genomics through protemics), pharmacokinetic method development, cell based assays and a range of other laboratory based research with our academic and private sector collaborators.
Veterinary Clinical Research
For veterinary clinical studies, Dr. Craig Woods is privileged to work with Arizona Animal Hospital in Scottsdale, Arizona, a state of the art facility that was ranked #44 on the list of America’s Best Veterinary Hospitals by USA Today. Arizona Animal Hospital is equipped with ultrasound, digital radiography, surgical suite, in-house laboratory and pharmacy, and cryostorage and has been a participating site in multiple veterinary clinical studies to help advance veterinary therapeutics and diagnostics.
Recent Animal Health Regulatory Updates
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request (January 7, 2025; 90 FR 1157)
Charter for the Jurisdiction Determination Process of the USDA CVB/FDA CVM Jurisdiction Committee (December 2024)
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2025 (July 31, 2024; 89 FR 61459)
New Animal Drug Approval Process
Video Links to the First Annual Drug User Fee Educational Conference (July 17th, 2024).
00:00:03 – Opening Remarks, Walt Ellenberg, Moderator
00:01:36 – Welcome, Dr. Califf (recorded message)
00:09:54 – Welcome, Matt Lucia
00:17:26 – Ground Rules/Overview, Walt Ellenberg
00:23:32 – INAD to NADA, Elizabeth Hasbrouck
01:02:01 – Communication Pathways with CVM, Annie Roa
01:35:40 – Best Practices in the Approval Process, Ana Lazo
01:51:48 – Best Practices in the Approval Process, Delisa Davis
02:09:07 – Q&A on the General Approval Process, Walt Ellenberg & CVM Panel
02:34:40 – Target Animal Safety Technical Section Overview, Target Animal Effectiveness, Prajwal Regmi
03:05:46 – Clinical Pharmacology, Mark Heit
03:16:07 – TAS & Effectiveness Best Practices, Cheryl Johnson
03:38:35 – TAS & Effectiveness Hot Topics, Andrew Fidler
03:44:44 – Chemistry, Manufacturing and Controls Technical Section Overview, Peter Bryk
04:11:31 – Human Food Safety Technical Section Overview, Kimon Kanelakis
04:29:51 – Human Food Safety Technical Section Overview, Jonathan Greene
04:37:34 – Human Food Safety Technical Section Overview, Heather Harbottle
04:46:51 – Environmental Impact Technical Section Overview, Holly Zahner
05:16:03 – Minor Technical Sections All Other Information, and Freedom of Information Summary, Labeling, Ann Stohlman
05:31:13 – Minor Technical Sections All Other Information, and Freedom of Information Summary, Labeling, Suzanne Sechen 05:45:42 – Q&A Session on Technical Sections, Walt Ellenberg & CVM Panel
06:13:53 – Closing Remarks, Walt Ellenberg