Virtual Plant for a Continuous Direct Compression Process– License Package Update Service for Process Automation Software, Engineering Software, and Virtual Controller Software
Key Dates
Due Date
-
Posted Date
-
Agency & Value
Agency
FDA Office of Acquisitions and Grants Services
Contract Value
Not provided
Codes & Classification
Solicitation Number
FDA-SSN-75F40126Q00214
NAICS
—
Classification Code
DA10
Additional Details
Documents1
The U.S. Food and Drug Administration (FDA), through its Office of Acquisitions and Grants Services, has issued a Sources Sought Notice (Procurement Identifier: FDA-SSN-75F40126Q00214) seeking information from qualified vendors regarding the provision of license maintenance and update services for process automation and engineering software. This requirement specifically supports the FDA’s Office of Pharmaceutical Quality Research (OPQR) in maintaining and updating the software infrastructure for a Pharmaceutical Manufacturing Virtual Plant.
The primary objective of this procurement is to secure ongoing license maintenance and update services for key process automation platforms, including SIMATIC SIMIT, SIMATIC SIPAT (Siemens PAT), and PCS7, or their equivalent solutions. These platforms are integral to the FDA’s virtual plant environment, which is used for continuous direct compression process simulation and pharmaceutical manufacturing research. The scope of work encompasses a one-year base period with four additional one-year option periods, ensuring sustained support and software currency over a potential five-year contract lifecycle.
Key requirements include the provision of timely software updates, license renewals, and maintenance services for the specified process automation and engineering software suites. The selected vendor will be expected to ensure that all software components remain up-to-date, secure, and fully functional, thereby supporting the FDA’s ongoing research and regulatory activities in pharmaceutical manufacturing. The deliverables will primarily consist of updated software licenses, technical support, and any necessary documentation to maintain operational continuity of the virtual plant systems.
This opportunity is classified under Product Service Code DA10, which pertains to IT and Telecom – Business Application/Application Development Software as a Service. The place of performance is Silver Spring, Maryland, within the United States. The procurement is set aside for Small Business Administration (SBA) eligible entities, indicating a preference for small business participation in alignment with federal acquisition policies.
The contracting activity is managed by the FDA Office of Acquisitions and Grants Services, a federal office under the Department of Health and Human Services. Interested parties are encouraged to review the full Sources Sought Notice and any associated attachments for detailed submission requirements. The primary point of contact for this notice is Terina Hicks, who can be reached via email at [email protected].
Contractors considering this opportunity should have demonstrated expertise in process automation software, particularly with Siemens platforms or equivalent solutions, and the capability to provide comprehensive license maintenance and update services over a multi-year period. The anticipated outcomes include uninterrupted software support for the FDA’s virtual plant, enabling advanced research and regulatory oversight in pharmaceutical manufacturing.
Responses to this Sources Sought Notice are due by June 23, 2026, at 17:06. Additional information and the official notice can be accessed via the SAM.gov opportunity page at https://sam.gov/opp/d502d9d16bbb443caba792966e33c3db/view.