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

We would like to provide our customers and the industry with an update on the status of LORENZ’ implementation of LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).

(Please click here to read our previous blogpost including a timeline of events from 1 July 2016 – 30 May 2017.)

02 June 2017 – New Bid Protest – B-414068.4

  • Synchrogenix Information Strategies LLC filed an additional bid protest with the United States Government Accountability Office regarding Solicitation Number 16-223-SOL-00073.
  • The decision for this protest is due by 11 September 2017.
  • Link:

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:

15 June 2017

  • Synchrogenix Information Strategies LLC received a 2 month extension of their existing contract with the FDA, ending 15 August 2017.
  • Solicitation Number 16-223-SOL-00073 remains pending FDA’s evaluation of updated proposals and the result of the pending bid protest filed on 02 June 2017.

17 July 2017

  • The FDA issued a new notice of intent to award a bridge contract to Synchrogenix Information Strategies LLC “for up to twelve (12) months to support the GlobalSubmit Review and GlobalSubmit Validate software.”
  • Link:

09 August 2017

  • Synchrogenix Information Strategies LLC received a 1 month extension of their existing contract with the FDA, ending 15 September 2017.
  • Solicitation Number 16-223-SOL-00073 remains pending FDA’s evaluation of updated proposals and the result of the pending bid protest filed on 02 June 2017.

30 August 2017

  • The FDA issued a new notice of intent to award a bridge contract to Synchrogenix Information Strategies LLC “for up to twelve (12) months to support the GlobalSubmit Review and GlobalSubmit Validate software.”
  • Link:

08 September 2017

  • The United States Government Accountability Office (GAO) denied the bid protest filed by Synchrogenix Information Strategies LLC on 02 June 2017.
  • Link:

11 September 2017 – New Bid Protest – B-414068.5

  • Synchrogenix Information Strategies LLC filed an additional bid protest with the United States Government Accountability Office regarding Solicitation Number 16-223-SOL-00073.
  • Link:
  • This protest was then withdrawn on 15 September 2017.

14 September 2017

  • Synchrogenix Information Strategies LLC received a 12 month contract award with the FDA, to allow continuity of operations, ending 15 September 2018.

– UPDATE –

22 December 2017

  • U.S. Government Accountability Office (GAO) dismissed the protest filed by Synchrogenix Information Strategies, LLC.  Shortly after GAO’s decision, FDA lifted the second stop-work order which was imposed on LORENZ on October 5, 2017 following the second kick-off meeting held by LORENZ and FDA.
  • Link:

16 January 2018

  • LORENZ and FDA resumed activities to implement LORENZ’s docuBridge, eValidator and Automator solutions in FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) electronic submission programs.  The implementation is expected to complete in 2018 and more information will be forthcoming.

 

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!

 

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s