. Feasibility assessment/ current 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 reliable adverse event reporting and safety update to Regulatory agency
📌 Medical Writer Bioequivalence Studies Gandhinagar (India)
🏢 Torrent Pharmaceuticals
📍 India
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.