i4i's Labeling Conversion Services

Solving Today's Regulatory Issues

Since June of 2009, the FDA has required more pharmaceutical and health care organizations to submit their product information electronically, in an XML format that is compliant with the Structured Product Labeling (SPL) standard.

As an XML pioneer and leading contributor to the development of the SPL standard, i4i possesses an intricate understanding of the FDA requirements. Thanks to this knowledge, i4i's products and services offer unparalleled speed and accuracy in the creation and migration of labeling documents to the SPL format.

i4i's conversion services can assist any part of the SPL creation process, ranging from full outsourcing to in-house conversions. Regardless of the kind of products you manufacture or distribute, we can transform your labels from any source format to SPL.

i4i Advantage at all levels

i4i's conversion services are delivered by experienced and knowledgeable personnel, using the patented technology of A4L—i4i's leading content authoring platform.

The combination of the A4L platform, experienced personnel, and a process-oriented testing methodology ensures quality and compliance. A4L ensures XML validation against the required schema files that are provided by the SPL Implementation and Guidance documentation.

In-depth validation is performed using the FDA's SPL validation rules, including OTC Monograph/CRF rules, Medication Guide validation, required content of labeling sections, and UNII code and moiety validation—to ensure that the SPL will be submission ready.

These processes support R4 requirements and standards, and ensure the validity and acceptance of your labels.

Methodology and Process

Our conversion cycle methodology follows these steps:

1. Analysis of source data.
2. Review of inconsistencies with client.
3. Creation of an FDA SPL.
4. Validation and quality assurance of the SPL.
5. Creation of the requested file format (if necessary).
6. Delivery of the submission package, by uploading it to our secure site—for client retrieval, review, and acceptance.
7. Submission through gateway.

i4i's Labeling Conversion Services assist you with all your labeling and listing needs. We can help manage the entire process, or fill in any area you'd like help with.

The end result is a compliant set of labels that can be re-purposed to various stakeholders across your organization.

Ask us what we can do for you.