Veterinary Drugs

Animals of all shapes, sizes, and species benefit from having access to animal drugs, veterinary biologics, and veterinary devices.  Not surprisingly, the regulatory challenges for these products is just as broad and complex.

Our firm has helped companies of all sizes and areas of focus with their regulatory and legal needs for their veterinary products.  Our years of experience with FDA’s Center for Veterinary Medicine and USDA’s Center for Veterinary Biologics has taught us one common lesson – consultation with an outside expert prior to talking with your regulator can be the most important investment your company ever makes.  We’ve seen the pitfalls of going to FDA or USDA without a clear understanding of the specific regulatory nuance that has the potential to upend your product development and marketing.

We are here to help.

Specifically, we can help with:

• Assessing whether your product is a veterinary device or whether FDA will consider your product to be a new animal drug
• Determining whether your product is regulated by FDA or USDA
• Interacting with FDA and USDA via formal meetings and informal communications
• Opening necessary investigational files (INADs)
• Developing efficient and pragmatic regulatory strategies
• Organizing and submitting data and information to support licensure or product approval
• Finding creative solutions to problems when issues with FDA or USDA seem intractable
• Preventing and avoiding regulatory surprises

Professionals