Latest Developments and Insights

Overview In the intricate world of drug development, the role of quality cannot be overstated. Ensuring the safety, efficacy, and reliability of pharmaceuticals is a cornerstone of the healthcare industry, as highlighted in the U.S. FDA’s Fiscal Year 2023 Report…

What is a biologic drug and how does it differ from a traditional small molecule drug? Biologic drugs have increasingly provided for broader therapeutic use over the last few decades and this trend is accelerating. As the first part of…

The simple answer is you save money, time and get an exciting new drug to the clinic for patients. What is Regulatory CMC and why do I need to pay attention to this during development? Regulatory CMC is at the…

Creating a successful regulatory strategy for drug development is important for venturing through the complex landscape of bringing new pharmaceuticals to market. This process makes sure that new drugs meet stringent safety and efficacy standards, making it a critical part…

The complete regulatory pathway for medical devices from concept to market is filled with intricate steps, evaluations, and planning. It’s an essential path for bringing safe and effective medical devices to the public. This process, while complex, is designed to…

Navigating the different phases of the regulatory pathway during drug development to achieve FDA approval is a complex and critical process every new drug must undergo. This process, essential for guaranteeing the safety and efficacy of medications, involves a rigorous…