Phase 3: Scale-Up & Commercial Tech Transfer
Process Parameter Freeze, CTD Modules 2 & 3 Drafting & Industrial Tech Transfer
The final stage-gate transfers validated formulation processes from Innoeco's micro-facility into the client's chosen commercial manufacturing site. Innoeco executes pilot-scale validation, freezes critical process parameters, compiles Common Technical Document (CTD) Module 2 and Module 3 filings, and provides comprehensive tech transfer support with 100% Foreground IP assignment.
• Master Batch Manufacturing Records (BMR) & Technology Transfer Package
• Common Technical Document (CTD) Module 2 (Quality Overall Summary) & Module 3 (Quality)
• Frozen Critical Process Parameters (CPP) & Critical Quality Attributes (CQA) Sheet
• Formal Handover Briefing & Foreground IP Assignment Certificate
Custom Scoping (Indexed to Baseline: R 12,500+)