Virtual Plant for a Continuous Direct Compression Process– License Package Update Service for Process Automation Software, Engineering Software, and Virtual Controller Software
Closed Pre-Solicitation Posted
- Solicitation number
- FDA-SSN-75F40126Q00214
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- Not on record
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA Office of Acquisition and Grant Services anticipates issuing a small-business set-aside solicitation for license maintenance and update services for pharmaceutical manufacturing process automation software (SIMATIC SIMIT, SIMATIC SIPAT, and PCS7 or equivalent), with capability statements due by June 23, 2026 at 1:00 PM Eastern Time. This market research phase precedes a formal competitive procurement; final set-aside determination will depend on responses received.
Performance spans a one-year base period (September 30, 2026 through September 29, 2027) with four one-year option periods extending through September 29, 2031, and takes place at FDA facilities. Required deliverables include digital twin software updates, concurrent method support, system extensions, 44 annual field service hours (including travel and on-site support), travel and living expenses, and perpetual-license digital copies on CD, DVD, or download. The contractor must provide two-business-day response to software defect inquiries, feature updates, technical assistance for platform troubleshooting, on-site support for license updates, and patch and helpdesk support.
The solicitation targets NAICS 513210 (Software Publishers) with small business size standard of $47.0 million. Interested vendors should submit capability statements to Terina Hicks, Contract Specialist, at Terina.Hicks@fda.hhs.gov. Questions are accepted through June 18, 2026. This notice is for market research only and does not constitute a binding commitment to award.
Notice text
The FDA/OPQR requires license maintenance service update for process automation software and SIMATIC SIPAT (Siemens PAT) software update service for a Pharmaceutical Manufacturing Virtual Plant via SIMATIC SIMIT, SIMATIC SIPAT, and PCS7 (or equivalent) for a One-Year Base with Four-Year Options Period of Performance.
Please review the attached Sources Sought Notice FDA-SSN-75F40126Q00214 document for more information.
Files
| File | Type | Posted |
|---|---|---|
| FDA-SSN-75F40126Q00214.pdf |
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