A global platform to connect, control, track & analyse
the content & data in your documents.

 
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Intelligent Authoring & Lifecycle
        Management of Structured Content


Accurate | Consistent | Compliant

Manage IDMP Data in Documents

IBs, SmPCs, and CMCs 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 and product 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.

And now the SPL format will be implemented by Health Canada in 2018 - learn more about Health Canada's SPM initiative here. 

Implement European Labeling

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

Go Global

Our Global Labeling platform combines our intelligent structured authoring tool with a robust set of dashboards that offer a suite of content creation, collaboration, and management features for all your drug product information, regulatory labeling and corporate document needs - across all jurisdictions.

Structured Content Authoring in Microsoft® Word

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

Manage the Full Lifecycle of Structured Content Documents

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

 

 

i4i Dashboard

A4L to provide easy submission process for the "blanket" No Changes Certification. The A4L Pro update will be rolled out in October to ensure compliance in a quick, timely manner. Our SPL DIRECT technical/regulatory team is already helping clients prepare their No Changes Certification submission for any products that have not/will not change in the 2017 calendar year. This annual submission window begins October 1st, with a hard deadline of December 31st, 2017. Contact us today if you have questions!

i4i joins the Technical Testing Pilot for the Structured Product Monograph (SPM). The SPM is Health Canada's HL7 SPL initiative and entry into structured content. i4i's Global Labeling Solution includes a Canadian PM structured content template, extending this to meet Health Canada's SPL standard will happen as the pilot unfolds and the guidance is finalized. Looking for more information? Talk to us today.

Our current release, A4L 5.6 offers the Risk Evaluation and Mitigation Strategies (REMS) SPL. Merging with the SPL initiative will make REMS easier to share and integrate into other health systems. If you are looking to submit your REMS submissions contact us today!

A4L 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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