PROTEST: FDA Electronic Common Technical Document (eCTD) solution

G2X TAKE: While the intent associated with this simplified acquisition” was to streamline procurement, the lone losing bidder is apparently not satisfied with the resulting award of this 5 year contract to provide software and services associated with implementing a Electronic Common Technical Document (eCTD) validation and review solution.

Awarded to Lorenz International, the eCTD solution is expected to be integrated into the electronic submission and review process, while this $7M contract award includes all maintenance and support.

Limited details have been provided as to the grounds for the protest. Protestor GlobalSubmit claims on their site that since 2005 they have ”been the U.S. Food & Drug Administration’s sole eCTD” solution and that the FDA relies exclusively on GlobalSubmit platforms to “evaluate the technical validity of 100% of the electronic submissions it receives.” 

Worth monitoring how this goes down as FDA has a significant number of electronic submission systems. This protest is expected to be resolved no later than March 2017.

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