Veterinary clinical studies and trials serve an important role in advancing products into the market place; helping to ensure they meet safety, efficacy and effectiveness requirements.

Like human drug development, veterinary medicine also has formal approval processes and study requirements for veterinary drug and biologics.  However, there are substantial differences between human and veterinary drug development requirements.   Craig Woods DVM, MS, MBA has managed and directed both veterinary and human clinical studies and trials; and appreciates the regulatory differences and the importance of clinical research.

• Study design
• Protocol development
• Study report forms

• Site selection and contracts
• Study implementation
• Study monitoring
• Closeout and audits

Our veterinary consulting services can provide transparency on the veterinary market, how a technology applies to animal health, and the market potential for their product or service.  In addition, we can assist clients determine if there are comparative disease targets to human diseases.

Our veterinary team is experienced in technology assessment, market research, target veterinary product profiles, distribution, and establishing the anticipated development timeline and budgets.

• Target Disease Applications
• Technology Feasibility
• Target Product Profile

• Market Research
• Attribute Mapping
• Competitive Analysis

• Development Timelines
• Development Budgets
• Technology Valuation
• Sales Forecasting

Our veterinary consultants have been involved in numerous licensing transactions, company start-ups, and the formation of strategic alliances.  We can help identify the right partners and provide guidance on when to engage those partners.  In addition, we have decades of experience in designing well balanced agreements, and can help in structuring licensing & distribution agreements, and other contracts associated with commercialization.

We can also assist in start-up formation, interim management, and building an online presence for investors or customers.

• Valuation and Financial Modeling
• Business Cash Flow and NPV
• Business Briefs and Plans
• Due Diligence and Licensing

• Go-to-Market Tactics
• Identifying Potential Strategic Partners
• Managing Negotiations

Before starting any project, one of the most important aspects to understand is the regulatory pathway.  Our veterinary consultants provide regulatory guidance for drugs, devices, diagnostics, and other veterinary products.  We can also help clients with regulatory submissions, project management, standard operating procedures, and requirements for evaluation of veterinary investigational products.

Quick Links:
Veterinary Clinical Trials
Veterinary Regulations

• FDA-CVM- Drugs
• USDA-CVB – Biologics
• Cellular & Regenerative Technologies
• VICH

• Investigational Product Accountability
• Project & Study Management
• Subject Management
• Site and Sub-site Management
• Study Feasibility Assessments
• Patient Recruitment Plans
• Site Monitoring Plans
• Study Auditing and QA

We have extensive experience in the creation of veterinary marketing materials, marketing strategy, and commercialization of veterinary drugs, nutraceuticals, biologics, devices and other products.  We also provide guidance on regulatory compliance of promotional materials, labels, brochures, websites, and documents.

In addition, we have over 10 years experience in website design and optimization to drive organic, high quality traffic using the WordPress content management system (CMS).

• Technical Papers
• White Papers and Reports
• Brochures and Flyers
• Labels, Inserts, and Box Art

• Hosting & Domain Registration
• Content Creation & WebSite Buildout
• Keyword & Site Optimization