Business
Case
Case
Initial report
go/no go
go/no go
Available routes report
go/no go
go/no go
Screening report
go/no go
go/no go
Full development
report & Tech Pack
report & Tech Pack
Approved
Process
Process
- Literature search
- IP/Patent search
- Paper Costing
- Feasibility testing of route
- Collection of initial data (analytics, yields, ...)
- Reaction screening and optimization
- Establishment of CPPs
- Optimization of workup
- Identification and purge of impurities
- Robustness and scalability testing
- Stress testing
- Analytical method specification
- MBR/BPCR, STP, Analytical reports
- Assistance with Validation and Filing
- Troubleshooting
- Long term stability tests