Medical Writing

Medical writing is a specialized form of technical writing that involves creating documents related to medicine, healthcare, and related fields.

Medical Writing Services Overview

Scientific Writing

  • Manuscripts
  • Abstracts
  • Posters
  • Create, update and maintain database for Standard Responses (FAQs)
  • Research and Review articles
  • PPT Presentations and Conference grids
  • Conference support
  • KOL Support
4C pharma solutions
4C pharma solutions

Clinical Writing

  • IBs, Study Protocols for CT and BE studies
  • CSRs (Full, Synopsis, Web Synopsis)
  • Subject Narratives
  • Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS)
  • INDs ARs/DSURs
  • IBs, Study Protocols for CT and BE studies

Reg & Post Marketing

  • Variations/amendments, Renewals and Annual updates
  • Manufacturing summaries
  • Process validation reports
  • Author/update labeling documents (CCDS, SmPC, USPIs, PILs) per PLR and QRD Template and other applicable guidelines
  • Author/update periodic reports (PSURs, DSURs, PADERs, PBRERs, CARs)
  • Safety Updates, Risk Management Plan (RiskMaps, EURMP) and Risk Benefit assessments
  • Summary Bridging Reports and Ad-hoc reports
Medical Writing

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