Prasanthi Malapati

At Viatris, I author and review CSRs, clinical protocols, and Investigator’s Brochures for Phase I–III trials, contributing to NDA/BLA submission components across biologics and immunology programs. I translate TLFs into clear regulatory narratives and manage document lifecycles in Veeva Vault and eCTD workflows.

Previously, I supported Phase II clinical documentation at Benaroya Research Institute, global submission documents and DSURs at BITS, and compliant medical content at Novartis. I bring a Ph.D. in Medicinal Chemistry and work closely with clinical development, biostatistics, safety, and regulatory teams to deliver accurate, evidence-based documentation.