Regulatory Operations

Source: inSeption Group
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Explore how inSeption Group's Regulatory Operations (RegOps) team is able to provide document-level publishing or management of the entire regulatory submission process.

Overview of Expertise

  • Document-level publishing services
  • Submission-level publishing services
  • Redaction and anonymizing services for public disclosure
  • Quality control of dossier
  • Electronic submission strategy
  • Strategic consulting
  • Expert knowledge of 21 CFR Part 11, eCTD, ICH, and other applicable regulatory requirements
  • Advanced use of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, and document publishing systems