Handling end to end Regulatory Affairs (Biosimilars) Operations for entire India and Europe regions.
Scientific advice, Slot applications and timetable management for various regulatory filings.
Clinical study and bio-analytical methods strategy development and documentation review.
Experience of process development, characterization and transfer for recombinant bio pharmaceutical products
Handling end to end Regulatory Affairs (Biosimilars) Operations for entire India and Europe regions.
Scientific advice, Slot applications and timetable management for various regulatory filings.
Clinical study and bio-analytical methods strategy development and documentation review.
Experience of process development, characterization and transfer for recombinant bio pharmaceutical products
