Collaborative Content for the Regulatory Process



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Intelligent Authoring & Lifecycle
        Management of Structured Content

Accurate | Consistent | Compliant

Manage IDMP Data in Documents

IBs, SmPCs, and PLs are just a sample of the documents rich in IDMP data. With i4i’s industry leading structured content solution, the gold standard for FDA SPL compliance, you can capture and manage key medicinal product information in your EU documents. Want to learn more about how to identify and harness the data in your product documents? Talk to us!

Achieve SPL Compliance

Employ i4i’s market-leading SPL solution, or i4i’s SPL creation and submission services, to ensure compliance for your FDA regulatory requirements. 

Implement European Labeling

Take full advantage of i4i’s content authoring and management solution to achieve European regulatory compliance. And now IDMP is part of i4i’s full labeling solution. Ask us how!

Author XML Documents in Microsoft® Word

Use the complete, familiar Word feature set in a fully functional XML authoring environment. 

Manage the Full Lifecycle of XML Documents

Extend the authoring platform to include document management and publishing, submission tracking, review cycles, content reuse and repurposing, and more.




In addition to aligning with the most current SPL validation and implementation guides, the A4L release, 5.4, offers full support to easily create valid Lot Distribution Report SPL's. Find out more about the FDA's latest submission requirement to adopt the SPL standard here.

i4i's recent R&D efforts have included a pilot project into global pharmaceutical content analytics. Initially we see a high value application to analysis of EU documents for IDMP data mining. Download the paper and read more.

i4i supports the regulatory requirements for the Medical Device community with their flagship pharmaceutical solution, A4L. For the full press release, click here.

Next generation of A4L Professional delivers enhanced performance. For the full press release, click here.




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