August 29, 2025

Understanding Changing Regulatory Demands in Pharma Process Development

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

Expanding Your Animal Health Portfolio: Regulatory Tips for Licensing and Acquisition    

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

From INAD to NADA: Mapping the Veterinary Drug Approval Lifecycle     

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 […]
August 26, 2025

Navigating the U.S. Animal Health Corridor: Key Trends for 2025 

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, […]
August 26, 2025

Reducing Pharma Supply Chain Risks with CMC-Driven Strategies

Pharmaceutical supply chains have never been under more scrutiny. From global raw material shortages and transportation bottlenecks to sudden shifts in regulatory requirements, today’s drug manufacturers face a range of logistical vulnerabilities that can disrupt development and production. These risks are not just operational they directly impact patient access, regulatory […]
May 7, 2025

The Role of CMC in Veterinary Medicine: Ensuring Regulatory Success from Development to Approval   

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 […]