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FDA / Health Canada Drug Listing Filing Support Services

Do you need help creating and filing labels with the FDA and/or Health Canada? Newbook can help. We provide the following SPL/XML PM related services:

  • Creation or update of existing Drug Listing
  • Conversion of MS Word or DTP formats to current filing guidance requirements
  • 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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