Current State of US FDA’s Electronic Common Technical Document (eCTD) Validation and Review Software Procurement and Implementation

We at LORENZ have been receiving an increasing number of emails and phone calls from our customers and partners concerning the current state of the project implementing LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).

In order to clarify the chain of events and alleviate any concerns, we are outlining below a timeline of events we hope will be helpful.

Solicitation, Award, and Kick Off

1 July 2016 – Solicitation Posted

  • FDA issued a Request for Proposal for the purpose of “establishing a contract to provide software and services associated with implementing Electronic Common Technical Document (eCTD) validation and review software that will be integrated into the electronic submission and review process. This includes maintaining and supporting the eCTD validation and review software.”
  • The solicitation (16-223-SOL-00073) was open to small businesses only, as defined by the U.S. Government size standards for industry.
  • Link:

30 September 2016 – Contract Award

  • FDA awarded LORENZ with the associated “Electronic Common Technical Document (eCTD) Validation and Review Software” contract on September 30, 2016 after evaluation of all submitted proposals.
  • The LORENZ solution was determined to provide the best value to the government at the least risk.
  • LORENZ proposed a timeline for implementation ending in June 2017, coinciding with the end of the incumbent contractor’s services.
  • Links:

6 October 2016 – Project Kick Off

  • LORENZ and FDA held a project kick off meeting at FDA’s White Oak campus in Silver Spring, MD. The meeting was attended by business and technical representatives from CDER, CBER, and FDA’s Office of Information Management and Technology.
  • LORENZ continued working with FDA, delivering documentation, plans, and other project deliverables, as required, throughout the month of October.

 Protests and Stop Work

7 October 2016 – Size Protest

  • The unsuccessful offeror, Global Submit, filed a size protest against LORENZ International LLC, alleging that LORENZ International LLC is not a small business because it “is affiliated with a family of international companies that bear the name “LORENZ” “.

 26 October 2016 – Bid Protest

28 October 2016 – Stop Work Order

  • FDA notified LORENZ of the award decision protest and issued a Stop Work Order in accordance with U.S. Federal Acquisition Regulations.

28 November 2016 – Size Protest Decision

  • The U.S. Small Business Administration (SBA) Office of Government Contracting, Area I (Area Office) issued Size Determination No. 01-SD-2017-008 (02-SD-2017-11), finding that LORENZ International LLC is an eligible small business for the procurement at issue.

8 December 2016 – Bid Protest Dismissal

14 December 2016 – Size Protest Appeal

  • An appeal was filed regarding the U.S. SBA decision, asserting that the size determination is clearly erroneous and requesting that the SBA’s Office of Hearings and Appeals reverse the decision.

18 January 2017 – Size Protest Appeal Denied

  • The US SBA’s Office of Hearings and Appeals concluded that LORENZ International LLC is indeed a small business eligible for award under the applicable regulations: “the appeal is DENIED and the size determination is AFFIRMED. This is the final decision of the Small Business Administration.”
  • Link:

 Request for Updated Proposals and a “Bridge” Contract

25 April 2017 – Updated Proposal Requested

  • LORENZ was invited by FDA to submit a new full proposal to meet the requirements of solicitation 16-223-SOL-00073.

22 May 2017 – Solicitation Number: FDA-SSS-17-1181839

  • FDA issued a new solicitation (notice of intent to issue a sole source award to GlobalSubmit).
  • This award being referred to as the FDA contract in certain communications our customers are receiving is a bridge contract for up-to-twelve months so that the FDA can continue in the short term to use its current tool, the contract for which was due expire in June 2017.
  • The nature of the short term bridge contract is outlined in the link below which some have been receiving as the FDA contract.
  • Link:

30 May 2017 – Updated Proposals Due

  • LORENZ submitted an updated proposal for solicitation 16-223-SOL-00073 to meet FDA’s long-term review and validation requirements including eCTD v4.0 implementation.
  • In accordance with the updated terms of the solicitation, LORENZ is proposing a transition-in period of 9 (nine) months from contract award.

UPDATE – 06 June 2017

  • As GlobalSubmit Inc. was acquired by Synchrogenix Information Strategies LLC on March 14, 2017, the FDA has issued a new notice of intent to award the bridge contract to Synchrogenix Information Strategies LLC.
  • The nature of the short term bridge contract is outlined in the link below which some have been receiving as the FDA contract.
  • Link:
  • Solicitation Number 16-223-SOL-00073 remains pending FDA’s evaluation of updated proposals to meet their long-term eCTD validation and review needs.

Many of the questions we have recently received relate to the new solicitation, FDA-SSS-17-1181839, the short term bridge contract being awarded to GlobalSubmit and Synchrogenix (the company which recently acquired Global Submit). In an ideal world, the LORENZ solution would have been operational in June 2017, however the project experienced multiple delays due to the bid protests outlined above and delays in FDA’s resulting corrective action.

We do understand FDA’s need to continue operations of their current eCTD tools and the need for the short term extension, but also want to clearly communicate that solicitation FDA-SSS-17-1181839 is not the new full eCTD contract being competed at FDA.

We look forward to the FDA’s evaluation of updated proposals for solicitation 16-223-SOL-00073 and the opportunity to support FDA’s electronic submissions programs in the years ahead.

Should you have any further questions or concerns, please contact your LORENZ account manager or simply call 1-866-9LORENZ. We would love to hear from you!

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