According to the most recent mandate from FDA, as of June 1, 2009 the following three types of communications required for Human Health (Prescription, OTC), Animal Health, Biologics and Vaccines organizations have to be in SPL – R4 standard:

  • NDC Labeler code request
  • Establishment registration and self-identification
  • Product listing and content of labeling

These communications have been submitted in paper form using Form FDA 2656, Form FDA 2657 and Form FDA 2658. With the new mandate sponsors are required to replace these forms with an electronic submission using the SPL – R4 format.

Navitas Life Sciences pharmaREADY SPL Center provides both technology and conversion services for the following sponsor companies to be compliant with SPL – R4 requirement.

  • Pharmaceutical
  • Biotech
  • Generics
  • Animal Health
  • Over-the-counter

The Navitas Life Sciences pharmaREADY SPL team can help companies convert their existing SPL R3 files to SPL R4 and get SPL R4 compliant.

The Navitas Life Sciences pharmaREADY SPL Center has extensive experience converting and creating thousands of labelling XML files fully compliant with SPL guidelines and accepted by FDA.


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