Free registration includes below SPL Services:

  • Dashboard
    • It gives the complete information about your files. It includes number of files you have submitted in the selected time frame, types of files etc. All this information you can see in both graphical as well as tabular format.
  • SPL Storage
    • Users can store the SPL files they own or manage for the owner for submission to the FDA. This is useful for future reference, more complete detection of potential validation errors, and for creating modified re-submissions as required. As well as querying and reporting on the user’s stored SPL data.
  • SPL Editor
    • Edit SPL XML files with SPL Editor and preview in the stylesheet view.
  • Validation Procedures
    • Validate SPL files against both, the W3C XML Schema and the extensive validation rules and submit to FDA.
  • Document Management
    • Features like compare, download SPL files you have uploaded, in .xml, .zip. and Microsoft Word formats.
  • ESG Registration and Submission to FDA
    • Register with Pragmatic ESG and submit SPL files to FDA.

Value added services

  • Assistance with rejection of SPL submissions due to validation errors at additional cost($50 an hour).
  • Correcting and advising on you SPL contents for submission to FDA at additional cost($50 an hour).