If you work in pharma, you know how much time and money go into drug development. The last thing you want is a painful FDA rejection, one that not only costs your company millions but also delays critical treatments for patients who need them. Regulatory rejections can happen for many ...

If you’re a biostatistician or clinical software developer, you’ve probably felt the weight of trying to meet GxP standards while navigating the FDA/EMA submission process. It’s not just about getting the software right—it’s about ensuring safety, quality, and compliance, all under tight timelines. It ...

GxP validation can be a complex and often misunderstood process, with each company implementing their own unique approach. During a recent roundtable I attended at the R/Pharma Summit in Seattle, there was a recurring theme that stood out to me – every company seems to have their own definition of ...