Medical Writing is a vital piece of the pharmaceutical business as it requires particular information and abilities to introduce the ideal logical data in a very much organized way.

At NAVATIOPHARMA, we have a group of specialists who other than having fantastic composing abilities can grasp the specialized language and tailor it to suit the prerequisites of the essential record.

REGULATORY WRITING

  • Investigational New Drug Applications (INDs)
  • New Drug Applications (NDAs)/Biologic Licensing Applications (BLAs)
  • 505(b)1 and 505(b)2 NDAs
  • Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
  • Annual safety reports, including Development Safety Update Reports (DSURs)
  • Briefing books for pre-IND/EOP2/pre-NDA
  • Regulatory responses
  • Prescribing information
  • Orphan drug requests
  • Fast track designation requests
  • Qualified infectious disease product requests (QIDP)

CLINICAL WRITING

  • Clinical Trial Protocols (Phase I to III)
  • Clinical Study Reports (Phase I to III)
  • Investigator Brochures
  • Patient narratives

SCIENTIFIC WRITING

  • Abstracts
  • Posters
  • Manuscripts
  • Literature-based research
  • White papers