SPL R4: i4i Launch coming soon...

i4i is pleased to announce its upcoming SPL R4 Portal with access to free Establishment Registration and Labeler Code Request Templates!
Click here to pre-register for an account and to be notified of the Official Launch date!

With the introduction of SPL R4, an exciting new chapter in the development of the SPL standard has come to fruition.

Not only has i4i Inc. used its patented technology and industry-leading solutions to continually help clients tackle SPL, we have used our knowledge and leadership to assist in driving this standard forward.  i4i has been very involved in the new SPL R4 (Registration, Listing and Labeling) requirements through our continued leadership role on the SPL Working Group. 

With this proven industry leadership, i4i has been working closely with the FDA on building the R4 Validation System (eList) through a Cooperative Research and Development Agreement.

What R4 Means to Industry:

As of June 1st, 2008 all Labeler Code Requests (LCR), Establishment Registrations (ER), and Content of Labeling will be submitted in SPL form.

Be ahead of the game, contact i4i to find out how you can author, review, and submit all of your SPL R4 content simply and easily, using our A4L platform.
Do not waste time with xForms!

Important Dates to Remember:

• October 8, 2008 - 11am FDA News Audio Conference - "The FDA's New Requirement for Electronic Regulatory Submissions:
  Will You Be Ready by June 2009"
  - i4i's own Keith Thomas will be giving a presentation on SPL R4.
   
• October 15, 2008 - CBER Biologics labels must be submitted in SPL R3 format.
   
• June 1, 2009 - All future SPL Registration, Listing and Labeling submissions in R4.