The global animal health market is evolving rapidly, with innovation driven by biotech startups, established veterinary companies, and crossovers from the human pharma space. For companies looking to expand their portfolio, licensing and acquisition remain two of the most efficient ways to bring new products to market without starting from scratch.
But with opportunity comes risk—especially when it comes to the regulatory and CMC complexity behind the scenes. In this article, we share key regulatory tips for companies evaluating animal health licensing or acquisition deals, and how to avoid surprises that could stall commercialization.
The Growth of Strategic Licensing in Animal Health
As new technologies emerge—such as veterinary biologics, microbiome-targeted products, and long-acting injectables—many companies opt to license promising assets rather than develop them entirely in-house.
Reasons for licensing include:
- Faster time to market
- Lower R&D burden
- Access to specialized delivery systems or formulations
- Geographic expansion (e.g., acquiring EU-approved products for U.S. distribution)
Whether you’re the licensor or licensee, regulatory due diligence is key to understanding what you’re getting—and what’s missing.
What to Look for in a Licensing Candidate
Before committing to a licensing deal, evaluate the following from a regulatory and CMC standpoint:
- Status of INAD or NADA (or international equivalents): Are there active applications with the FDA’s Center for Veterinary Medicine (CVM) or EMA/CVMP?
- CMC documentation: Is there sufficient detail on the drug substance, drug product, manufacturing process, and analytical methods?
- Stability and shelf-life data: Are studies VICH-compliant? Do they cover all dosage forms and packaging?
- Manufacturing facility status: Is the site FDA-inspected? Is GMP compliance documented?
- Species-specific considerations: Are excipients justified? Is the product appropriate for its labeled use in the U.S.?
- Post-approval commitments: Are there any known deficiencies, safety updates, or pending supplement requirements?
Acquisition Considerations: Buying an Approved Product
When acquiring an already-approved veterinary drug (e.g., a product with an NADA or ANADA), the focus shifts from development to compliance and lifecycle planning.
Important questions include:
- Are manufacturing transfers required? If so, how will FDA be notified?
- Does the product have a clean inspection history (483s, warning letters)?
- Are there outstanding CVM questions or post-approval commitments?
- Is the regulatory history accessible, including all submission components?
- Will new studies be needed to expand indications, change labels, or update formulations?
Acquiring a marketed product may seem turnkey, but integration requires careful regulatory planning—especially if you intend to scale production, change vendors, or relabel under your own brand.
Common Regulatory Pitfalls in Licensing & Acquisition
Even experienced teams can miss key issues during portfolio expansion. Common missteps include:
- Assuming CVM will accept foreign data without bridging studies
- Overlooking species-specific excipient concerns
- Failing to verify data traceability or GLP/GMP compliance
- Assuming a “complete” dossier when key modules are outdated or missing
- Underestimating the time and cost to update or supplement regulatory submissions
How DSI Supports Portfolio Expansion
DS Inpharmatics helps companies de-risk licensing and acquisition decisions by offering:
- Regulatory due diligence—a full review of CMC data, submission history, and compliance status
- Gap assessments to identify what’s missing or out of date
- FDA engagement strategy for post-licensing updates or supplements
- Support for tech transfers, site changes, and lifecycle management
- U.S. market entry planning for EU or APAC-based companies seeking to expand
Whether you're in-licensing a novel animal biologic or acquiring a mature brand, our team ensures your regulatory house is in order before the deal closes—and well beyond.
Final Thoughts
Licensing and acquisition can be powerful tools for growth—but without regulatory clarity, they can also lead to hidden costs and lengthy delays. By asking the right questions up front and partnering with experienced advisors, you can ensure your animal health portfolio expansion delivers the results you're aiming for.
Need help with regulatory due diligence or post-acquisition support?
DS Inpharmatics is ready to assist with every step—from technical evaluation to CVM strategy. Contact us today to learn more.
