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QbD-Expert
Consultancy
QbD-Expert QbD Project Consultancy

QbD-Expert™ provides complete "T" suite of Consultancy for Development & Implementation of

Quality by Design System for Novel & Generic Drug Product; starting from 1) Target Product Profile Definition

2) Determination of CQAs with Impact Analysis 3) Quality Risk Assessment for API & Excipients Material Attributes

4) Quality Risk Assessment for Processing Parameters of Mfg Process 5) Designing of Experiments

6) Design Space Development 7) Validation of Design Space 8) Execution of Exhibit Batches

9) Finalization of Control Strategies for CMAs, CPPs, IP CQAs & FP CQAs

10) Continuous Process Monitoring Plan for Commercial Mfg.

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