Structured Product Labeling

Start-to-Finish Structured Product Labeling Submissions that Comply with Industry Standards

Structured Product Labels (SPLs) are a small component of full eCTD submissions, but they can pose an equal amount of difficulty for your regulatory team if technical specifications and data requirements are not fully understood. Synchrogenix offers start-to-finish expert outsourcing services for a variety of structured product labeling submissions including:

  • NDC Labeler Request
  • Establishment Registration
  • Product Label
  • Dietary Supplement Labeling
  • Generic User Fee Facility Self Identification

Without at least a working knowledge of extensible markup language (XML) structure and FDA expectations related to an SPL submission, there is a high probability that you will encounter technical issues and spend considerably more time on the submission process than an expert would require.

Five Potential Problems to Avoid When
Creating a Structured Product Label (SPL)

Synchrogenix’s team is very familiar with the intricacies of XML and SPL requirements. We can create the SPL from content you supply and run validation checks prior to FDA submission. Our eCTD publishing team can identify, interpret and correct critical errors to prevent rejection and the need for multiple submissions.

If you are grappling with an SPL that has been rejected, we can analyze the error reports and correspondence with the Agency, correct errors and submit your SPL through the ESG gateway.