gSOLIDS Licenses

Awarded Award Notice Posted

Solicitation number
19-FDA-SOL-1210258
Agency
Food and Drug Administration Department of Health and Human Services
Awarded
to Siemens Process Systems Engineering Inc.
Set-aside
Total Small Business

Opportunity facts

Contract number
75F40119P10197 Federal contract award
NAICS code
541512 Computer Systems Design Services
PSC
Not on record
Place of performance
U.S. Food and Drug Administration Center for Drug Evaluation and Research 10903 New Hampshire Ave Silver Spring, Maryland 20993, United States

Notice details come from SAM.gov. Updated .

Notice text

2 versions

Update #2 · Latest ·

Awarded Vendors: Process Systems Enterprise Inc.. Contract Award Dollar Amount: $49,960.00. Contract Award Date: 2019-05-21.

Update #1 ·

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.
The Food and Drug Administration intends to award a sole source firm-fixed price purchase order to Process Systems Enterprise Inc., 3 Wing Dr. STE 103, Cedar Knolls, NJ, 07927-1002 in accordance with FAR part 13.106-1(b)(1)(i). This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 and 13.
Please see attachment for the complete requirements.
Background

The Office of Pharmaceutical Quality/ Immediate Office (OPQ IO) utilizes the gSOLIDS modeling software for systematic risk assessment of continuous pharmaceutical manufacturing processes. gSOLIDS contains the capabilities to provide dynamic, high-fidelity models and advanced model validation, process optimization and custom modelling capabilities in addition to the basic, steady-state models available in general solids process modelling tools. gSOLIDS have the following applications: 1) Extract better kinetic information from fewer experiments; 2) Quantify the risk associated with imperfect knowledge of process; 3) Design information rich experiments; 4) Flexible and reliable continuous process. This software is approved for use on the FDA Network.


Objective/Scope


The objective is to renew the existing gSOLIDS license in accordance to the delivery schedule. The licenses shall be term licenses.

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Attachments

Files attached to this notice, newest first
File Type Posted
19-FDA-SOL-1210258.pdf PDF

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