Save 80% of Time and Money on FDA 2253 Submissions

Zinc Ahead has announced a game-changing ability to directly submit post-marketing submissions through the FDA’s electronic submissions gateway, saving clients 80% of the time and money involved in this previously time-consuming process.

The FDA recently announced that from 15 June 2015 they will accept Promotional 2253 submissions in eCTD using the new Module 1 (v3.3). Life Sciences companies will be required to submit all Post-marketing Promotional Materials (Form FDA 2253 Submissions) and Pre-submissions of Promotional Materials for Accelerated Approval Products (subpart H and subpart E) electronically 24 months after their final guidance is issued.

Zinc’s flagship product, Zinc MAPS, offers an end-to-end process which facilitates the review, approval and direct eCTD submission to the FDA gateway in a contained, compliant software solution and will be available on the date that the gateway opens. No other third party integration products are required.

Zinc clients have the option to either directly submit the eCTD Submission package from Zinc MAPS to the FDA ESG or they can choose to have the eCTD Submission package delivered to their desktop or a secure server.

“Zinc continues to monitor the industry and stay ahead of its clients’ needs through continuous innovation in its product solutions,” said Dom Eaton, President of Product & Professional Services at Zinc. “Our latest enhancement to the Zinc MAPS product provides our clients a solution to streamline a submission resulting in reduced time and costs associated with compiling, packaging and shipping submissions to the FDA. Our clients can realize a savings of up to 80% with this solution versus manual submission preparation and physical materials.” 

Zinc will enhance this functionality with the release of Zinc MAPS v15 which will convert the 2253 submission package into a validated eCTD format. Other enhancements to the 2253 submission process in Zinc MAPS v15 include the ability to create multiple submissions for jobs containing products from different centers and/or application types, the ability to edit submissions before sending to the FDA, the ability to create submissions of jobs that share a primary or secondary brand, the ability for the 2253 Admin to filter jobs on Brand, Audience and Dissemination Date, and enhancements to the 2253 Admin area.

Dale Cooke, an independent FDA regulatory expert at PhillyCooke Consulting said: “Making eCTD submissions available now shows that Zinc is committed to making the submission of post-marketing promotional materials to the FDA fast and simple. This gives Zinc clients the ability to begin implementing eCTD well ahead of it becoming a requirement and will help companies ensure compliance.” PhillyCooke Consulting helps companies develop compliant communications for FDA-regulated products.