Too Early for GxP? The Costly Assumption Many Biotechs Make
“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…
A Real-World Case: The Investors Didn’t Question the Science
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…