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FDA SPL Filing Support Services

Do you need help creating and filing labels with the FDA? Newbook can help. We provide the following SPL related services:

  • Update existing SPL Labels
  • SPL R5-compliant document authoring
  • Conversion of SPL R3 Labels to SPL R5 Listings
  • Conversion of non-PLR content into PLR structure.
  • Data entry for NDC Labeler Code Request, Establishment Registration and GDUFA Self Identification forms
  • Drug Listing training and mentoring for in-house SPL submission authors

Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for a demonstration and pricing.

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