Medical Writing And QC

Source: inSeption Group
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inSeption provides medical writing services as well as strategic submission planning expertise to ensure that your application is of the highest quality. Our highly experienced, fully dedicated team integrates with your organization to credibly manage the complexities of timeline creation and management, resourcing, document interdependencies, and transmission through the Electronic Submission Gateway (ESG).

Medical Writing

  • Global regulatory submissions, Modules 2-5 of the eCTD
  • CSRs (Phase 1-4)
  • Orphan Drug Applications
  • Investigator’s Brochures
  • Clinical Protocols and Amendments
  • Safety Narratives
  • Annual Reports
  • Briefing Books
  • Responses to agency questions
  • Pediatric Study Plans and Pediatric Investigation Plans
  • Publications (abstracts, posters, manuscripts)
  • Public disclosure writing

Quality Control

  • 100% QC of all documents
  • Verification of consistency across all documents

Regulatory Operations and Submissions

  • Document-level formatting and publishing
  • Publishing and maintenance of eCTD submissions
  • Transmission to health authorities (ESG)
  • Strategic consulting and process optimization

Overview of Expertise

inSeption’s Global Regulatory Documentation Group provides seamless collaboration on documents and submissions throughout a spectrum of services: medical writing, quality control review, document- and submission-level publishing, and health authority submission management. We have the flexibility to manage all aspects of
your regulatory writing program, either as a fully-dedicated partner or as individual contributors to fit within your existing team.