Regulatory Operations

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Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system, we can oversee all technical aspects for submission of your dossier. 

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