Managing information requests from health authorities such as the FDA is a critical aspect of regulatory compliance for pharmaceutical companies. These interactions can directly affect the pace of your product's approval process. To succeed, it's important to follow best practices that focus on clarity, accuracy, and efficient project management.

What is a Biosimilar? In the scientific realm, biosimilars, akin to their reference products, are biologic medications. Approval for biosimilars hinges on demonstrating no clinically significant differences in safety and efficacy compared to the reference products.

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.