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Princeton, NJ, United States, 2015/06/15 - Zinc Ahead today 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. NYSE: VEEV
The FDA recently announced that from June 15, 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. Read the full guidance here.
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. Additional information about PhillyCooke Consulting can be found at PhillyCooke.com
About Zinc Ahead
Zinc Ahead (zincahead.com) is the leading enabler of content compliance and rich media management for the life science industry. Two million digital assets have been approved through the Zinc cloud, transforming the digital media development and compliance community in 170 countries. More than 50,000 marketing, medical and legal professionals are using Zinc daily, and its products are widely recognized as the gold standard in life sciences compliance software and rich digital media management.
Zinc empowers users to collaborate, approve and share content in real-time with colleagues and third party agencies anywhere in the world. Combining best-of-breed functionality with an intuitive interface, Zinc enables fast, secure approval of all types of materials including print documents, rich digital media files, apps and websites.
Zinc Ahead is a privately owned company with headquarters in the United Kingdom and operations in the United States, Central Europe, and Asia.