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FDA Selects November Research Group’s PRIMO as Product Vigilance Solution

Mackson Consulting, a strategic partner of November Research Group, is the prime contractor for the project. PRIMO will be used by the Center for Food Safety and Nutrition (CFSAN).

Berkeley, CA and Reston, VA (PRWEB) December 20, 2016

November Research Group, LLC, a global leader in the delivery of product vigilance software to leading biopharmaceutical and medical device manufacturers and regulators, is proud to announce that the company’s PRIMO product vigilance solution has been selected as the new product vigilance software solution for the United States Food and Drug Administration’s (FDA) Center for Food Safety and Nutrition (CFSAN). Mackson Consulting, a Woman Owned Small Business (WOSB) and strategic partner of November Research Group, is the prime contractor for the CFSAN project. Mackson Consulting has broad industry expertise, as well as extensive experience collaborating with the FDA providing award winning IT solutions and professional services.

“We chose to propose PRIMO as it was the clear industry leader in Commercial off the Shelf (COTS) solutions in the market, that could meet the review and analysis requirements of the FDA,” stated Mary Biear, President of Mackson Consulting. CFSAN joins the FDA’s Center for Devices and Radiological Health (CDRH) in selecting PRIMO to replace their legacy adverse event systems with a solution geared toward the new era of proactive risk management. CFSAN’s responsibilities span the food and cosmetic industries, which includes the labeling of dietary supplements and food ingredients, post market surveillance and compliance of the food industry, and the safety of cosmetic ingredients. Unlike other commercial AE systems, PRIMO leverages a contemporary architecture to deliver a comprehensive risk management platform built to address the complexity of the challenges faced by manufacturers and regulators. PRIMO provides automation of routine activities while delivering superior analytics and insights.

“While PRIMO brings a contemporary solution to the market, it was Mackson’s deep understanding of the CFSAN analysis and case management requirements and their stellar reputation that drove our decision to join their team,” said Tim Howard, President of November Research.

About November Research Group

November Research Group is a Berkeley, CA based software development company dedicated to delivering commercial product vigilance products for the risk management era. The core team of software developers and quality assurance engineers have been developing software in this domain for over 20 years. They have lead and participated in the development of the most adopted software solutions in this space, including EventNet/Oracle AERS, Relsys/Oracle Argus, and PRIMO. The PRIMO product vigilance platform is positioned to address one or all of the daunting regulatory challenges facing life science groups to provide a Part 11 Compliant solution to inbound email, streamline case intake and triage, deploy mobile and portal AE/PC intake, manage global partner and regulatory submission commitments, and provide medical user access to pharmacovigilance data using powerful queries, all while leveraging an open architecture that embraces integration with emerging cognitive computing technologies.

About Mackson Consulting

Mackson Consulting LLC, is a Women Owned Small Business (WOSB) delivering IT services to the commercial and public sector markets, with a strong track record delivering on health information technology (HIT) modernization efforts. With a focus on systems engineering modernization and data management solutions, Mackson has been successful in the delivery of health modernization efforts including, but not limited to clinical trials data management and adverse events. Mackson received three separate and distinct industry honors in 2015 including the ACT/IAC 2015 Mobile Technology Award for Best Business investment of the year and multiple awards for innovative health modernization efforts. Mackson continues to lead the industry with expertise in federal health and professional services support.


John Cheevers, Director of Sales, November Research Group LLC, john(dot)cheevers(at)novemberresearch(dot)com

Mary Biear, President, Mackson Consulting LLC, mary(dot)biear(at)macksonconsulting(dot)com

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