Medical Writing

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We author documents that support research and development and marketing needs.  Our expertise includes clinical study protocols, clinical study reports, Investigator’s brochures, briefing documents, safety narratives, and Modules 2 to 5 of the CTD.

  • Write documents to fit Client’s strategic regulatory plans
  • Act as primary point of contact with Client
  • Develop granular document timelines
  • Ensure integration of inter-dependent content across documents
  • Provide planned continuity for inter-program and post-submission writing activities (RTQs, safety updates)
  • Manage writing team resource assignments proactively
  • Manage document budgets

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