SPL Authoring

SPL Authoring

eCTD Publishing, SPL Authoring & More

Send a Submission (404) 496-4171

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. Aquila specializes in drafting SPLs with thorough quality checks and ensures that we provide expertise in this creation. This includes:

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This includes:

Drug Labels

  • Human Prescription
  • Human OTC
  • Bulk Ingredients
  • Cellular Therapy
  • Drug for Further Processing
  • Packaging Insert Creation

Registration

  • Establishment Registrations/De-Registrations
  • Labeler Code Activations & Inactivations
  • No-Change Notifications

Other SPLs

  • Dietary Supplements
  • Cosmetics

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