SPL Portal

FDA XML Submission Management

This robust solution was designed by Intagras to provide pharmaceutical manufacturers web-based software to create, maintain, and submit SPL submission files. This software provides full compliance for the FDA's submission standards and is continuously updated as regulations are modifed. The following FDA submissions are supported by SPL Portal:

  • Prescription Products

  • Over-the-Counter Products

  • Animal Products

  • Active Pharmaceutical Ingredient (API) / Bulk / Drug for Further Processing Products

  • Contract Manufacturing Organization (CMO) Products 

  • Establishment Registrations Files

  • NDC Labeler Codes Files

  • Lot Distribution Reports

  • ACA Reports

  • Wholesale Drug Distributor/3PL Registration Files

  • Blanket No Change Certification Files

 

Key features include:

  • Centralized XML Repository

  • Real-Time Validation 

  • Software Updates for New Guidance Issuance 

  • Support Team Access

  • And more...

 

Support for Health Canada SPM submissions coming soon!

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