May 6, 2025
The veterinary pharmaceutical industry is at a crossroads as shifting consumer behaviors, economic pressures, and evolving market demands shape the future of companion animal medicines. While the global animal health market continues to grow, stagnation in the small animal sector and a decline in canine wellness visits have presented significant […]
May 6, 2025
Good Manufacturing Practice (GMP) audits play a critical role in ensuring the safety, quality, and efficacy of veterinary pharmaceuticals and biologics. These audits assess compliance with regulatory requirements set forth by agencies such as the FDA’s Center for Veterinary Medicine (CVM) and the USDA’s Center for Veterinary Biologics (CVB). Non-compliance […]
May 2, 2025
Introduction Navigating the regulatory landscape for veterinary pharmaceuticals and biologics can be complex. The U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) and the U.S. Department of Agriculture’s Center for Veterinary Biologics (USDA CVB) oversee different aspects of veterinary product approvals. FDA CVM regulates veterinary drugs under […]
April 25, 2025
Navigating the complexities of drug development demands more than internal resources. From overcoming technical hurdles and avoiding costly or inappropriate development paths to meeting regulatory standards, every stage—discovery to market—presents unique challenges. At key moments, companies must recognize when external expertise isn't just helpful but crucial. Partnering with the right […]
April 18, 2025
Discover the five pillars of drug development consulting: regulatory compliance, clinical trials, preclinical research, CMC, and market access.
April 4, 2025
The Center for Biologics Evaluation and Research (CBER) plays a critical role in overseeing the approval of innovative biologic products, including gene therapies, cell-based treatments, and vaccines. While CBER and the Center for Drug Evaluation and Research (CDER) jointly evaluate breakthrough therapy designations, CBER focuses on advanced biologics, ensuring timely […]
