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.



This topic contains 0 replies, has 1 voice, and was last updated by  G2Xchange Editor 2 years, 8 months ago.

  • Author
  • #23177
     G2Xchange Editor
    • Web Site Editor
    • G2Xchange

    Replies viewable by members only

You must be logged in to reply to this topic.


Questions?. Send us an email and we'll get back to you, asap.


©2019 G2Xchange all rights reserved (new) | Community and Member Guidelines | Privacy Policy | About G2Xchange Health

Federal Government Employees Join Free

As a special thank you to all the federal agencies that have been supportive of our efforts over the years we offer a free individual membership to Federal Government employees.  Membership includes:

Full Access to the G2Xchange Health website, including exclusive member content.

Access to Forums, Comments, and Discussions

Member Directory

Private Messaging

The G2Xchange Health Daily Take Newsletter which includes the latest intelligence, news, and happenings from across the Federal Health IT Market.

Exclusive Discounts on G2Xchange Events and G2Xchange Partner Events.

Click Here to Join


Opportunities. Starting Points.

About our Data

The Vault is a listing of expiring contracts, task orders, etc. within a certain set of parameters, to include:

  • Have an initial total estimated contract value of $10 million or above
  • Federal Health Only – MHS/DHA, HHS, CMS, or VA Actions
  • NAICS codes include: 511210, 518210, 519130, 519190, 541511,
    541513, 541519, 541611, 541618,
    541690, 541720, 541990
  • Were modified within the last 12 calendar months
  • The data represented is based on information provided by the government

Who has access? Please note that ALL G2Xchange Health Members will receive access to all basic and much of the advanced data. G2Xchange Health Corporate Members will receive access to ALL Vault content (basic and advanced).

Feedback/Suggestions? Contact us at and let us know what you think. 

Log in with your credentials

Forgot your details?