Blog

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 […]

The animal health industry is evolving rapidly, driven by advancements in veterinary medicine, increased demand for innovative treatments, and changing regulatory requirements. Companies seeking to bring new veterinary drugs, biologics, and feed additives to market must navigate a complex regulatory landscape that spans multiple agencies, including the FDA Center for […]

Introduction  The demand for veterinary biologics is on the rise as advancements in biotechnology pave the way for innovative treatments in animal health. Unlike traditional pharmaceuticals, veterinary biologics—such as vaccines, monoclonal antibodies, cell and tissue derived products and gene therapies—offer targeted mechanisms of action with fewer side effects. However, navigating […]

The veterinary sector is undergoing a transformation driven by economic pressures, shifting consumer behaviors, and evolving regulatory landscapes. Rising costs and changing pet ownership trends have led to a decline in veterinary visits, particularly in the companion animal market. As companies navigate these challenges, optimizing regulatory efficiencies, Chemistry, Manufacturing, and […]

Introduction Bringing a new veterinary drug to market is a time-consuming and resource-intensive process. To address urgent animal health needs, the FDA’s Center for Veterinary Medicine (CVM) offers the Conditional New Animal Drug Approval (CNADA) process, which provides an expedited pathway for certain veterinary drugs. This blog explores how the […]