Research and Development Department-Pre-Lab activity.
- Project initiation form
- Team & Resource allocation
- Literature search,- Sci finder, Reaxys, etc.
- Preparation of product dossier – Part A (IPM)
- Route selection/costing,/Consultation with IPR etc. – Part B (CR)
- Indent of RMs, innovator tablet
- Preparation of project timelines
- Apply for licenses such as Form-29, Form-11
Research and Development Department – Lab activity.
Feasibility studies
- Finalization of ROS
- Cost evaluation
- EHS
- Lab Expt. Execution
- Preparation of “Feasibility Study Report”
Optimization
- Develop a process upto100g scale
- Optimization of process
- Parameter study
- Operational parameters
- Significant parameters
- Critical parameters
- DOE
- Safety report preparation
- Development Report from R&D (Product Dossier C)
Validation
- Development of analytical method and validation
- Analytical testing method
- STP
- Method Validation
- Stability study
- Development Report from AR&D (Product Dossier D)
Meeting
- Technology Transfer meeting
