Project Life Cycle
OBJECTIVE | PHASE - 1 PLANNING | PHASE - 2 GRAM SCALE | PHASE - 3 KILO SCALE | PHASE - 4 COMMERCIAL |
---|---|---|---|---|
Technical | Enquiry By Customer | Up to 500 gms | Technology scale up | Technology transfer plan |
Commercial agreement with CDA | Synthesis Development | Engineering and validation batches | Final Validation | |
Technical Interaction | Analytical Development | Process risk analysis | Final Specification | |
Technical Interaction | Preparation of Master Formula | CTD Preparation | ||
Customer Advantage | Cost Estimation | Lab Samples | Regulatory support for stability, Impurity Profile, Degradation Studies etc. | Final quotes for commercial quantities |
Commercial agreement with CDA | Lab process | |||
Technical Interaction | Waste Management Focus | Compiling Regulatory Requirements | ||
Feasibility Studies | Analytical Data | Material for further Development work | ||
Quote - Evaluation 1 | Safety / Ecology Data | |||
Time Schedule | Within 2 weeks | 3-20 Weeks | 4-12 Weeks | 20-24 Weeks |