November 20, 2025
The Contract Development and Manufacturing Organization (CDMO) landscape is evolving—and animal health is quickly becoming one of the most sought-after segments. As pharmaceutical sponsors increasingly focus on strategic outsourcing, many CDMOs that once served only human health are now expanding into veterinary manufacturing to capture a fast-growing market with unique […]
November 20, 2025
Chemistry, Manufacturing, and Controls (CMC) data is often one of the most underestimated elements in veterinary drug development. Yet when it comes time to prepare an FDA submission—whether an INAD or a full NADA—incomplete or misaligned CMC information is one of the leading causes of delay. For companies seeking a […]
October 27, 2025
If you’re a human-health biotech or pharma company eyeing the animal-health market, you’re not alone. Pet-owner spending, food-animal productivity pressures, and “One Health” thinking have pushed more human-first innovators to explore veterinary indications, either by repurposing an existing asset or launching a dedicated animal program. The opportunity is real, but […]
August 29, 2025
Pharmaceutical process development is not a static undertaking. Regulatory expectations continue to evolve, demanding deeper process understanding, enhanced control strategies, and comprehensive documentation throughout the development lifecycle. For companies aiming to bring new therapies to market efficiently and compliantly, staying aligned with these changes is both a challenge and an […]
August 27, 2025
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 […]
August 27, 2025
For companies developing new animal health products in the United States, understanding the transition from Investigational New Animal Drug (INAD) to New Animal Drug Application (NADA) is key to regulatory success. While these acronyms may seem similar, they represent two distinct phases in the veterinary drug development process—one focused on […]
