Medical Writing
4C Pharma Solutions

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)
4C Pharma Solutions

CLINICAL WRITING

  • CSRs (Full, Synopsis, Web Synopsis)
  • Subject Narratives
  • Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS)
  • INDs ARs/DSURs
  • Medical Rationale documents
  • PPT Presentations and Conference grids
  • Conference and KOL support

4C Pharma Solutions

SCIENTIFIC WRITING

  • Posters and Newsletters
  • Patient Support Programs (PSPs) and Market Research Programs (MRPs)
  • Create, update and maintain database for Standard Responses (FAQs)
  • Research and Review articles

Medical Writing Feature

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