Hygenix Blog

Is Your Facility Ready for Remote FDA Assessments? | Hygemix, Inc.
July 14, 2025
Is Your Facility Ready for Remote FDA Assessments?

The FDA published final guidance on Remote Regulatory Assessments (RRAs) on June 26, 2025, in “Conducting Remote…

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Cleanroom Strategy Meets Digital Innovation | Hygenix, Inc.
June 28, 2025
Cleanroom Strategy Meets Digital Innovation

Imagine testing hundreds of production scenarios in a virtual model of your cleanroom before a single piece of…

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A Smarter Way to Invest and Scale | Hygenix, Inc.
June 23, 2025
A Smarter Way to Invest and Scale

Pharma and biotech teams struggle with rising capital investment, tight timelines, and complex manufacturing…

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RFK Jr.’s FDA Overhaul Is Here | Hygenix, Inc.
June 09, 2025
RFK Jr.’s FDA Overhaul Is Here

In a …

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Why Pharma Projects Fail Before They Start | Hygenix, Inc.
June 02, 2025
Why Pharma Projects Fail Before They Start

Skilled labor is in short supply, and project schedules aren’t getting any easier. Teams often have enough people,…

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FDA’s AI Push
May 19, 2025
FDA’s AI Push

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

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

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

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