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Pharmaceutical Industry Solutions

Newbook provides comprehensive solutions for FDA Structured Product Labeling (SPL) and Health Canada XML Product Monographs that served drug manufacturers and medical device manufacturers. labelBridge currently includes the following capabilities:

  • Supports SPL Listing submissions, Establishment Registrations and NDC Labeler Code Request forms
  • Supports HC XML PM submissions in both official languages
  • Built-in SPL codes to ensure fast and accurate data entry
  • Intuitive forms and interface, minimizing the end-user XML knowledge required
  • Powerful side-by-side compare functionality
  • Role-based user management and complete audit trail
  • Fully threaded annotations to enhance the SPL review process
  • Powerful SPL and XML PM validation to meet US FDA and HC submission filing requirements

Review our labelBridge product information, or contact us using the form below.

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