Hygenix Blog

What GMP Buyers Will Screen for in 2026 | Hygenix, Inc.
October 20, 2025
What GMP Buyers Will Screen for in 2026

In pharma, buyers check everything. If your team can’t survive a 10-minute document pull and two Part 11 questions…

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FDA Precheck is Redefining Facility Readiness | Hygenix, Inc.
October 13, 2025
FDA Precheck Is Redefining Facility Readiness

In August 2025, the FDA launched the PreCheck program, reshaping how new pharmaceutical…

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Quality Management Maturity Is Moving From Pilot To Practice | Hygenix, Inc.
September 08, 2025
Quality Management Maturity Is Moving From Pilot To Practice

Quality Management Maturity (QMM) is voluntary today, yet the direction is clear. The FDA’s Center for Drug…

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Poor Bids Start with Poor Requirements | Hygenix, Inc.
August 04, 2025
Poor Bids Start with Poor Requirements

If your User Requirement Specification (URS) isn’t ready, your project isn’t ready to go out for bid. Yet this is…

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the cGMP Trap No One Talks About | Hygenix, Inc.
July 28, 2025
The cGMP Trap No One Talks About

Commissioning is complete. The cleanroom passed IQ and OQ. On paper, the facility looks ready. But when the first…

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Municipalities Are Stepping In to Solve the Lab Space Crisis | Hygenix, Inc.
July 21, 2025
Municipalities Are Stepping In to Solve the Lab Space Crisis

Startups in biotech, diagnostics, and clean tech often struggle to find affordable, fully equipped lab space.…

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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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