Electronic Submissions publishing

FMD K&L can assist you to derive full benefit from an electronic submission system, while providing support to ensure smooth, efficient implementation
Regulatory Affairs:Electronic Submissions Publishing

FMD K&L publishing services offer full lifecycle management of the submission process with flexible options for report-level publishing, submission publishing, compilation, and lifecycle maintenance. Our regulatory affairs professionals are experienced in an array of electronic formats, including structured product labeling (SPL), electronic common technical documents (eCTD), and non-eCTD electronic submission (NeeS).

SPL conversion services

We have extensive experience converting and creating SPL XML files to be fully compliant with SPL guidelines.

Our SPL conversion services include creation of SPL submission packages to FDA for:
  • NDC labeler code registration
  • Establishment registration
  • Drug listing and content labeling

The SPL team supports eSubmission gateway setups and provides guidance in creating validated SPL submission packages. Our validated SPL R4 submission packages include SPL R4 documents in an XML file for delivery to the customer and uploading to the FDA submissions gateway.

For every label conversion assignment, our deliverables include:
  • An FDA-ready, submittable SPL package containing the converted XML file, associated molecular images & all other relevant images
  • A conversion service worksheet providing transparency on the conversion approach & a conversion service report summarizing tasks executed during the conversion

eCTD submission services

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

  • Document/report level publishing
  • Regulatory submission level publishing
  • Document and submission quality control

FMD K&L offers services for each of these processes.

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 hyperlinked table of contents
  • Hyperlinking internal documents
  • Quality control on all document navigation

We provide regulatory submission level publishing services for the full spectrum of regulatory submissions. We can help prepare electronic submissions to satisfy regional or global business objectives.