With the submission period for the new Blanket No Changes Certification for Product Listing SPL beginning October 1st, i4i's SPL DIRECT regulatory and technical team has already begun preparing the No Changes Certification SPL for some clients. A4L Pro will be rolled out in October, in time to make the path to compliance and submission creation process quick and easy for all our clients to meet the December 31st deadline.
Have questions? Contact our team for more information.
August 30th, 2017
FDA adds new SPL submmission types. Earlier this week, along with the latest release of the Structured Product Labeling (SPL)
Implementation Guide with Validation Procedures (Revision 201708281242), the FDA announced it would start accepting 6 new SPL types in October of this year. i4i is adding these new submission types and implementation/validation updates to our A4L development plan and will keep clients posted on the support and release dates.
i4i participates in Health Canada's Technical Testing Pilot for the Structured Product Monograph (SPM). The SPM is Health Canada's HL7 SPL initiative and entry into structured content for their Pristine Product Monograph submissions.
The kick off meeting took place on June 7th, with the pilot expecting to run through March 2018. We are actively engaged in the pilot, partnering with sponsors, assisting with sample submissions and helping prepare for a quick and seamless adoption.
A natural fit for i4i's flagship A4L solution which has been managing SPL creation and updates since the FDA mandated the SPL submission format in 2005. Current implementations of our Global Labeling Solution offer the Canadian Product Monograph and we expect the evolution of this structured content template to the new HC SPM guidelines to be a smooth transition.
i4i remains committed to delivering comprehensive and easy-to-use structured authoring and content management solutions, that are first to market and best-in-class to comply with Health Authority standards.
Need more information? Get in touch with our team today.
March 29-31st, 2017
i4i preps for Scotland!2017's annual DIA EuroMeeting is being held in Glasgow, Scotland and i4i will be there. This flagship event allows industry professionals to debate the issues across the entire drug development value chain during the conference & find solutions within the exhibition with 2,500+ other cross functional thought leaders. A unique opportunity to learn from experts, network with influencers and collaborate with solution providers.
Do you have questions about Structured Content and how it will streamline the content process across your organisation? Chat with our industry experts at booth D9, C15!
February 6-8, 2017
i4i joins the DIA RSIDM in North Bethesda, MD.Covering Electronic Regulatory Submissions (ERS), Regulatory Information Management (RIM), and Electronic Document Management (EDM), this conference serves as the premier place for the discussion of emerging operational standards, best practices, and the processes for submission, creation, and maximum use of regulatory information. This forum touches on i4i's core strengths and expertise creating innovative solutions for business operation processes in the Life Sciences sector. We look forward to discussing how structured content solutions can streamline your regulatory processes and requirements. If you are going to be there, take a moment to connect with our team at booth 207!
Best Wishes from i4i! It is always a pleasure helping our valued clients reach their goals year after year. As new regulations and opportunites unfold we look forward to contributing to further successes in 2017.