Navigating Regulatory and Patent Challenges in the Combination Products Space The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a [...]

Prepare Your Quality Management System for QMSR Compliance by February 2026 With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for [...]

You’ve heard the term, “cure-all”, I’m sure, but as we all know, there is no real “cure-all” in life. If you ever watched the movie, “My Big Fat Greek Wedding”, then you are all too familiar [...]

Every so often, I take the time to catch up on the FDA’s findings that result from the latest audits of drug, device, biologics and combination product manufacturers. It always astonishes me as to how [...]

In the realm of drug manufacturing, sterile products continue to pose challenges. With process failures identified nearly every year, improvement is a continual goal. This has led to exciting innovations such as barrier systems, innovative [...]

For your pharmaceutical company, reducing operating costs and improving service are possible with a large-scale supply chain transformation. While this kind of extensive reworking of your supply chain may seem intimidating and unnecessary, it can [...]