Hygenix Blog

On May 12, 2025, the FDA announced it would expand its use of generative AI across regulatory review processes,…

After an initial surge of reshoring announcements, 2025 has ushered in a more cautious phase for pharmaceutical…

In the last quarter, the FDA has issued a wave of warning letters and import alerts to pharmaceutical and medical…

Cleanroom construction is more than a capital project—it’s a compliance-critical investment that directly impacts…

Cleanroom construction sounds straightforward—design it, build it, validate it. But in reality, most projects go…

The pharmaceutical industry is experiencing a significant shift as companies increasingly consider reshoring…

If you’ve worked on cleanroom construction or facility upgrades in the life sciences industry, you know the drill—…