- Feasibility assessment/ new product evaluation
- Literature review and BA/BE study designing
- BE Study Monitoring
- Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.)
- Establishment and maintenance of study documents
- Document preparation for dossier submission (i.e clinical overview, non-clinical overview,
summery tables etc.)
- Review of BE study documents i.e protocol, reports, ICF etc.
- Preparation/review of medical write up
- Coordination for responsible adverse event reporting and safety update to Regulatory agency