SPL Services Whitepaper Minimize the effects of a new and constantly changing standard

Intagras firmly believes that a change in your business process is a change to what has made and sustained the success of the company. (read more)

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What is SPL?
Structured Product Labeling (SPL) defines the content of human prescription drug labeling in an XML format. It is approved by Health Level Seven (HL7) and has been adopted by FDA as a mechanism for exchanging medication information. Since October 31, 2005, labeling submissions to the FDA's Center for Drug Evaluation and Research (CDER) must be in SPL format. (Click here for more information)

Who is Affected by the FDA SPL Guidance?
All pharmaceutical companies that currently must comply with the FDA's drug listing and registration regulations.

These include:
  • Human Prescription Products
  • Human Prescription Generic Products
  • Over the Counter Products
  • Biologics
  • Veterinary Medicines
  • Medical Devices

How Can Intagras Help You Remain Compliant?
There are several different approaches to compliance. Intagras provides a full service outsourcing approach that allows for continued authoring in Microsoft Word using your current business processes. Intagras will provide you with the following deliverables as part of our standard SPL services package:

  • SPL content of labeling XML submission file
  • SPL image files
  • Scrubbed Word document
  • Proprietary product data elements review page
  • Proprietary SPL content review page
    • LOINC code identification
    • Hyperlink association confirmation
    • Subsequent submission section change confirmation

This approach offers the most flexibility for our clients. Since the first SPL implementation, there have been four updates to the guidance. For customers that have opted for a software approach, these updates have meant software changes and additional training. Our approach requires no software update, no process changes, and no additional training within your organization. It's business as usual.

What Does Intagras Provide that Other Outsourcing Vendors Don't?
Our standard SPL service offering provides you with the industry’s most experienced resources and technology. While other service providers charge you extra for emergency turnaround conversions and subsequent submissions, we include that offering in our base price.

Our industry experts have over three years of experience in identifying and properly formatting the product data element information. This service is part of our standard service offering. Other service providers will require that you provide them with this information in a spreadsheet. Our approach will save you the time associated with collecting this data and will ensure compliance with SPL guidelines for data structuring.

So, what sets our SPL management approach apart from our competitors?

  • Unparalleled customer service
  • Unmatched industry knowledge
  • All inclusive flat rate
  • 100% Referenceable client list
  • Secure file transfer
  • Progress tracking
  • Unlimited SPL downloads
  • Proprietary secure SPL portal

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