QbD – DOE – QRM
DMF & ANDA Review
Life Cycle Management
- We provide the training and travel along with team on QbD based Method and Product development in turn enable the team for making PDR with appropriate scientific/ risk-based knowledge.
- We assess the available PDRs/ methods/ specifications and guide the team for identifying early gaps (deficiencies).
- Help and facilitate the teams in defining lifecycle management / appropriate specifications for their products.
- Provide the training on statistical tools which enable the team for developing the standards for their methods/ processes.