FMD K&L can assist you to derive full benefit from an electronic submission system, while providing support to ensure smooth, efficient implementation
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.
- 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.
- 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.
- 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.