When pursuing a Biologics License Application (BLA) or New Drug Application (NDA), meeting timelines is crucial. However, the path to approval is often fraught with potential delays. Understanding these risks—and knowing how to mitigate them—can make or break your timeline. Top 10 most common risks and expert tips on how to manage them effectively

Step into the dynamic world of medical writing at Synterex and discover a day in the life of our talented medical writer, Cheryl Kolus. 

When preparing regulatory submissions, especially in fields like oncology, it's crucial to focus on the end goal—the drug's label or Summary of Product Characteristics (SmPC). These documents aren’t just regulatory requirements; they serve as the foundation for how the drug will be positioned in the market.

Today’s Employee Spotlight is on Taylor Friend, one of our amazing medical writers. Read our Q&A with her below. 

As Americans, we tend to be very insular in our thinking. Since we don’t generally need to know another language, most of us don’t understand anything but English. Since we typically have far fewer vacation days than other countries, our vacations tend to be short.

People started becoming afraid of aspartame after its labeling as “possibly carcinogenic to humans” by the World Health Organization (WHO) on July 13, 2023. Since then, there has been ongoing discussion about aspartame’s carcinogenic potential.  What is aspartame?