Virtual Biotech — Quality Oversight Model
CMC quality oversight for virtual biotech organisations — Discovery to Out-Licensing
QULLA Partners
Richard van Ewijk
qulla.bio
GLP zone
GMP — Phase I
Phase II +
Knowledge management
CMO / CRO output complexity
Sponsor QA oversight
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quality cursor
Three quality oversight curves across virtual biotech development stages from Discovery to Out-Licensing.
Knowledge Management
Horizontal — development stage
Discovery — Pre-GLP
Vertical — quality system layer
Knowledge management & documentation
Quality activities at this stage & layer