New Molecule approved for trials (Internal Product Development)
- Investigational product
- Investigational product setup
- Existing Case data import
- LP Reporting rules set up
- Safety data exchange mechanism between Company & LP
Clinical trial Phase
- Clinical trial set up
- Investigational licenses set up
- RA Expedited Reporting rules set up
- Periodic Reporting set up
Acquired Products/ Jointly developed with License Partners (LP) – CT phase
Marketing + Post Marketing Surveillance Phase
- Product transition from Investigational to Marketed
- Marketed Licenses set up
- RA Expedited Reporting rules set up
- Periodic Reporting set up
- Post Marketed Studies set up
Acquired Products/ Jointly Marketed with License Partners (LP) – MKT phase.
Product Discontinued / Licensing agreement matured
- Product/License deactivation
- Expedited Reporting rules de-activation
- Case data archival /Export (in case of License partner according to agreement)
- Investigational product setup
- Existing Case data import
- LP Reporting rules set up
- Safety data exchange mechanism between Company & LP