Animal Health Consultants
Veterinary Consulting Services
-veterinary clinical studies
-regulatory strategy and submissions
-animal health market research & analysis
-technology assessment and development plans
-business development & licensing strategy
Since 2007, our animal health consultants have provided strategic guidance to veterinary companies, start-ups, and human biomedical companies seeking to enter the animal health market. Our services are provided by licensed veterinarians and experts with decades of industry, academic, start-up and private practice experience; affording our clients key insight from concept to market.
Veterinary Clinical Studies
Our veterinary consultants have decades of experience in designing and implementing veterinary clinical studies. As the approval processes for licensing veterinary drugs and biologics varies depending on the regulatory jurisdiction, we first ensure the that veterinary studies are developed and implemented in compliance with regulatory standards.
For example, veterinary pharmaceuticals (e.g., veterinary drugs) are regulated by the FDA-Center for Veterinary Medicine whereas veterinary biologics (veterinary vaccines, immune modulators, and certain diagnostic kits) are regulated by the USDA-Center for Veterinary Biologics. Animal Health Consultants can help clients navigate the regulatory requirements for conducting pilot and pivotal studies for drugs, biologics, medical devices and other veterinary products. A few areas we can assist with are listed below:
Data analysis and reporting
Veterinary Regulatory
Before starting any project, one of the most important areas to consider is which agency has jurisdiction for the veterinary product or service, as there are different requirements depending on if the product is defined as a veterinary drug, biologic, animal medical device, or other type of veterinary product. Animal Health Consultants can help define the regulatory pathway and what requirements apply. If there is ambiguity, our veterinary consultants can obtain regulatory confirmation from the FDA-CVM or USDA-CVB.
Afterwards, we can prepare submissions to the appropriate veterinary regulatory agency, create development plans and standard operating procedures, and manage the regulatory approval process for veterinary drugs, biologics, diagnostics, cell-based therapies and other veterinary products. A few areas we can assist with are listed below:
FDA CVM Submissions
Investigational New Animal Drug Files
ADUFA fee waivers
MUMS and risk based reviews
Veterinary Master Files
USDA-CVB Submissions
Veterinary clinical study protocol designs
Outlines of Production
Plot plans and blueprints
Business Development
Our veterinary consultants have been involved in numerous licensing transactions, veterinary start-ups and the formation of strategic alliances. We can help identify the right partners and have decades of experience in negotiating and executing well balanced agreements including excluslive licensing & distribution agreements for veterinary drugs, biologics and devices. We can also assist in start-up formation, provide interim management, and create financial and technical information for investors or customers.
Veterinary Business Development
Valuation and financial modeling
Business briefs and plans
Identifying strategic partners
Managing negotiations
Veterinary Technology Agreements
Term Sheets, Letters of Intent
Licensing & Distribution Agreements
Veterinary Market Analysis
Our veterinary consulting services provide transparency on the veterinary market and the market potential for the veterinary product or service. In addition, we can determine if there are comparative disease targets to humans which can advance both human and veterinary medicine in parallel. Our veterinary consulting team is highly experienced in technology assessment, market research, target veterinary product profiles, distribution, and establishing the anticipated development timeline and budgets.
Technology Assessment
Target disease applications and technology feasibility
Target product profile and attribute mapping
Veterinary market research and competitive analysis
Development Plans & Financials
Development timelines and budgets
Technology valuation
Sales forecasting
For all new clients, we can provide a free 30-minute consultation to discuss our veterinary consulting services, the project, and needs of the client.
Quick Links:
Veterinary Clinical Trials
Veterinary Regulations