Emerging advanced therapy biotech
A digital PQS blueprint for a scaling therapy biotech
Batch review cycle
An emerging advanced-therapy biotech was scaling operations for Phase 2 trials while its QA team worked on disconnected, spreadsheet-based quality systems.
The challenge
Batch release ran on disconnected spreadsheets, with batch review averaging 8-10 days as the team scaled for Phase 2.
The approach
We delivered a digital blueprint: identification and quantification of opportunities, an implementation strategy, and multi-vendor evaluations and recommendations.
The impact
Implementation strategy with detailed multi-vendor evaluation assessments, leading to a recommended vendor with full total cost of ownership modelling.
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