i4i's Conversion Services

Solving Today’s Regulatory Issues

The FDA now requires more pharmaceutical and health care organizations to submit their product information electronically, in an FDA mandated Structured Product Labeling (SPL) format that is compliant with the eXtensible Markup Language (XML) standard.

As an XML pioneer and leading contributor to the development of the Structured Product Labeling standard, i4i offers unparalleled speed and accuracy in the creation and migration of labeling documents to an FDA-compliant SPL Label.

i4i's Conversion Services are available for all of your labeling requirements. Whether you are a Human Rx and/or Generic, OTC, Biologic, or Veterinary Medicine product manufacturer, i4i's Conversion Services Team can efficiently transform any of your labels from source (Word, Pdf, Quark, XML) to compliant SPL.

From outsourcing just one label, or even your entire library of of Product Inserts, i4i can provide you the ability to effortlessly convert, manage, and submit your entire labeling content across all product lines.

Methodology and Process

i4i’s tested and well defined process-oriented methodology for label conversion ensures character-level conversion accuracy and conformance to both the FDA’s SPL standard and ISO-governed XML standard.

Within this methodology is a quality process that includes the following steps: 

1. Analyze Source Data

2. Review Inconsistencies with Client

3. Generate XML Data in conformance with FDA SPL and W3C XML Standards

4. Perform Validation

5. Perform Quality Assurance

6. Option to Render Requested Format [doc, rtf, pdf, etc.]

7. Post the SPL submission package on our secure site for client retrieval and acceptance.

i4i Advantage at all levels

i4i’s conversion services are based on experienced, knowledgeable personnel and patented technology that underlines i4i’s leading SPL structured content & authoring platform; A4L.  The combination of the A4L platform, a process-oriented methodology and experienced personnel ensure quality and compliance; users do not have to worry about the details of the XML tags or system code.

The technology surrounding the A4L content authoring and conversion platform ensures XML validation against the required schemas governed by the FDA's SPL Implementation and Guidance documentation.  These processes support all R3 and R4 requirements and standards to ensure the validity and acceptance of your labels.

All SPL Formats Accepted