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.