Veterinary Medicine

Introduction  In the veterinary pharmaceutical and biologics industry, Chemistry, Manufacturing, and Controls (CMC) play a crucial role in ensuring product safety, efficacy, and regulatory compliance. CMC encompasses the critical steps involved in drug development, from formulation and manufacturing processes to stability testing and quality control. As regulatory agencies such as […]

From Kansas City to Columbia, the U.S. Animal Health Corridor is home to the largest concentration of animal health companies in the world. With over 300 animal health businesses and research organizations, this region has become a global hub for innovation, partnerships, and investment in veterinary medicine.  For emerging sponsors, […]

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 […]

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 […]

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 […]

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 […]