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 conversion 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.
 

 

 

Announcements

FDA extends SPL Guidance to include Lot Distribution Reports. This latest regulatory requirement goes into effect June 2015, read more here.

i4i supports the latest regulatory requirements for the Medical Device community with A4L release 5.3. 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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