Following our successful participation in the FDA's pilot program, i4i is ready to offer Risk Evaluation and Mitigation Strategies (REMS) SPL submission services. 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!
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.