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 uniquely challenging regulatory environment. The complex landscape of global regulations [...]

With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for this significant regulatory shift. This updated regulation will replace the current [...]

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 [...]