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Electronic Submissions Publishing

ClinChoice assists biopharmaceutical companies in maximizing the benefits of electronic submission systems while providing support to ensure smooth, efficient implementation.

ClinChoice publishing services include complete lifecycle management of the submission process with flexible options for report-level publishing, submission publishing, compilation, and lifecycle maintenance for drug products and drug substances (DMF and ASMF). Our regulatory affairs professionals work in an array of electronic formats, including electronic common technical documents (eCTD), non-eCTD electronic submission (NeeS), paper submissions, and structured product labeling (SPL).

eCTD submission services

The electronic publishing process leading to a regulatory submission may be divided into five processes:

  • Document/report level publishing
  • Regulatory submission level publishing
  • Fit and finish activities
  • Document and submission quality control
  • Submission of the published package to the health authority via an electronic portal and archival of the document, including healthy authority correspondence

 

Our services for document/report level publishing include:

  • Scanning paper content
  • Converting documents into PDFs according to regulatory guidance
  • Creating bookmarks matching table of contents
  • Creating a hyperlinked table of contents
  • Hyperlinking internal and external documents
  • Ensuring that documents are well-formatted, complete, and legible (pertinent to old legacy reports)
  • Quality control on all document navigation
  • Resolve publishing errors
  • Converting legacy paper-based submissions to eCTD
  • Creating baseline submissions
  • Quick turnaround on responses to queries to reduce overall approval time
  • Provide regulatory and strategic advice for managing the lifecycle of registered products as per market regulations
  • Customized Quality Control checklist for each submission type