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“We are too early for a GxP system.”
It is a sentence many early-stage biotech companies say with good reason. The team is small. The science is still evolving. Capital is limited. Internal processes need to remain flexible. A shared drive, spreadsheets, CRO portals and email approvals can feel sufficient for the current stage.
The problem is…

The science was strong. The Phase I study was progressing well. The management team believed they were ready.

A biotech startup with 18 employees was preparing for its first major investor due diligence round. But…