January 28, 2026
For virtual biotechs and lean startups, choosing the right Contract Manufacturing Organization (CMO) is one of the most important decisions in early development. The right partner can be the foundation for smooth IND filings, clinical supply readiness, and future commercialization. The wrong one? It can trigger delays, regulatory issues, budget overruns—and even force you to change vendors […]
January 13, 2026
For CMOs and CDMOs based outside the United States, serving U.S. clients is a major growth opportunity—but it also comes with heightened scrutiny. U.S. sponsors rely heavily on their manufacturing partners to meet FDA CMC and GMP standards, especially when preparing regulatory filings like INDs, NDAs, and BLAs. If your site or processes fall […]
January 13, 2026
At the core of every successful drug development program lies a reliable, scalable Active Pharmaceutical Ingredient (API) manufacturing process. From early discovery chemistry to commercial supply, designing an API process that evolves efficiently through each phase is critical to meeting regulatory expectations, clinical timelines, and commercial goals. Yet many programs […]
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 […]
