December 11, 2025

The Role of Target Animal Safety Studies in Regulatory Approval      

Bringing a veterinary product to market requires demonstrating that the product is not only effective, but also safe for the animals it is intended to treat. Central to that demonstration is the Target Animal Safety (TAS) study, a required component of nearly every New Animal Drug Application (NADA) submitted to […]
December 10, 2025

What Investors Look for in Animal Health Startups (Hint: It’s More Than Just the Science) 

Great science is essential—but it’s not enough to attract investors in today’s competitive animal health landscape. Funders are looking for startups that understand the full journey from R&D to regulatory to revenue—and can execute it with clarity, confidence, and the right partners.  Whether you're pitching at the Animal Health Summit […]
December 10, 2025

API Process Validation: How to Design a Strategy That Works 

Process validation is a critical milestone in the drug development journey, particularly for API manufacturing. An effective validation strategy not only meets regulatory expectations—it ensures a controlled, well-understood process capable of consistently delivering high-quality API throughout the product lifecycle.  But process validation isn’t a one-size-fits-all exercise. Requirements evolve from early […]
December 2, 2025

API Supply Chain Risk Mitigation: Planning for Disruptions Before They Happen 

The global pharmaceutical supply chain is more fragile than ever. COVID-19, geopolitical tensions, raw material shortages, tarrifs and logistics disruptions have exposed vulnerabilities that can directly impact API availability and costs.  In this blog, we explore how to build a resilient API supply chain—and why proactive planning matters more than […]
December 2, 2025

5 Red Flags in CMC That Scare Away Investors 

Investors and strategic partners expect technical risk when evaluating early-stage drug development programs. However, certain CMC (Chemistry, Manufacturing, and Controls) red flags are immediate causes for concern—and can quickly lower valuations, delay deals, or even derail partnerships altogether.  Here are five of the most common CMC issues that investors view as […]
November 20, 2025

How Due Diligence Differs in Animal Health vs. Human Health 

Due diligence is a cornerstone of investment and acquisition decisions—but in animal health, the process plays by a slightly different set of rules. While many human health investors are familiar with INDs, CDER, and clinical trial design, the animal health world brings its own regulatory structures, product formats, and commercial […]