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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…

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…

One of the first recommendations that I received as an entry-level medical writer when I started writing clinical study protocols (or simply called protocols) was “not all protocols are created equally”. This may seem obvious, but as I gained more…

A regulatory affairs project manager (RAPM) is a pivotal figure in the compliance and regulatory integrity of products or drug development within the biopharma industry. This role demands a comprehensive understanding of biopharma-specific regulations, meticulous project management skills, and effective coordination with…

Understanding the intricacies of navigating regulatory affairs for clinical trials is pivotal in shaping the path to successful medical research and innovation. These regulations form the backbone of ensuring that your trials are not only compliant but also set up…