Hygenix Blog

FDA’s AI Push
May 19, 2025

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

Reshoring Is Evolving—Not Retreating | Hygenix, Inc.
May 12, 2025

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

Avoid the 483 Letter | Hygenix, Inc.
April 21, 2025

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

How to Choose the Right Cleanroom | Hygenix, Inc.
April 14, 2025

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

8 Pitfalls That Derail Cleanroom Builds | Hygenix, Inc.
April 07, 2025

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

Reshoring Is Reshaping the Pharmaceutical Industry | Hygenix, Inc.
March 24, 2025

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

Stop Wasting Money on Change Orders | Hygenix, Inc.
March 17, 2025

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