Be Inspection-Ready in 6 weeks.
The Problem
- FDA and EMA inspections can halt funding, delay trials, or trigger costly 483s
- Most biotech teams struggle with disorganized documentation and unclear roles
- Fixing inspection failures later costs 2-3x more than preparing up front
Our Solution
- Four-week program: Gap scan, Document fix, Team training, Mock audit
- Focuses on hot spot areas like data integrity, change control, and risk files
- Blends plain-English coaching, templates, and hands-on drills for lasting readiness
Why Us?
- Proven biotech startup expertise- speaking both science and regulator
- Interactive, low-stress process that builds team confidence and control
- Delivers a complete, audit-ready document set and a culture of inspection readiness
bluebaybiotech.com 