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SW-63958 - USA (Maryland) - RFI for Lorenz eCTD Software - Deadline December 2,2022

Product (RFP/RFQ/RFI/Solicitation/Tender/Bid Etc.) ID: SW-63958

Government Authority located in Maryland; USA based organization looking for expert vendor for Lorenz eCTD software.

[*] Budget: Looking for Proposal

[*] Scope of Service:

Vendor needs to provide determine the availability and capability of supplying, enterprise-wide license along with support and maintenance of the Lorenz eCTD validation and review software that has been integrated into the electronic submission and review process.
1) The Contractor shall have the capability to obtain an enterprise-wide license of the Lorenz eCTD software.
2) The Contractor shall have the experience and capability to perform maintenance of the Lorenz eCTD software.
3) The Contractor shall be capable to modify and upgrading the Lorenz eCTD software.
4) The Contractor shall be capable to deliver and install new versions of the Lorenz eCTD software after any modification/upgrades.
5) The Contractor shall be capable of supporting the FDA’s effort to test and implement software product releases in the FDA test and preproduction environment prior to release/implementation in the FDA production environment. This includes addressing and resolving issues identified during the release/implementation process.
6) The Contractor shall be capable to support CDER and CBER with their own center-specific implementations of the software.
7) The Contractor shall be capable of integrating eCTD COTS software interface with each center’s tracking system to display regulatory information.

[*] Eligibility:

- Onshore (USA Organization Only);

[*] Work Performance:

Performance of the work will be Offsite. Vendor needs to carry work in their office location.

Expiry Date : Friday, 2 December, 2022

Category : Software, System and Application

Country : USA

State : Maryland

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