December 22, 2025
Regulatory starting material (RSM) selection and justification can make or break your API CMC strategy. Regulatory authorities such as the FDA and EMA carefully scrutinize RSM designations, and inadequate justification is a frequent cause of information requests, delayed approvals, or even refusal to file. Selecting the wrong starting material—or failing to justify it properly—can trigger extensive […]
December 11, 2025
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
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
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
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
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 […]
