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.

Recent Animal Health Regulatory Updates