Virtual Plant for a Continuous Direct Compression Process– License Package Update Service for Process Automation Software, Engineering Software, and Virtual Controller Software
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), specifically the Office of Pharmaceutical Quality and Research (OPQR), is conducting market research through a Sources Sought notice to identify qualified sources for license maintenance service updates for process automation software and SIMATIC SIPAT software. This requirement supports a Pharmaceutical Manufacturing Virtual Plant utilizing SIMATIC SIMIT, SIMATIC SIPAT, and PCS7 (or equivalent) software. This is a Total Small Business Set-Aside, though other than small businesses are also encouraged to respond. Capability statements are due by June 23, 2026.
Scope of Work
The FDA/OPQR requires license maintenance service updates for process automation software and SIMATIC SIPAT (Siemens PAT) software. This includes services for a Pharmaceutical Manufacturing Virtual Plant via SIMATIC SIMIT, SIMATIC SIPAT, and PCS7 (or equivalent). The anticipated services include:
- Digital Twin: Software Update Service for Process Automation Software
- SIPAT: SIMATIC SIPAT Concurrent Method Support
- ProcessCare - Plus: PA Process Care Contract - Plus
- ProcessCare - Plus System Extension
- Field Service Hours (including travel and on-site time)
- Field Service Travel and Living Expenses
Minimum contractor requirements include delivery of software updates, testing, two-business-day response to defects, availability of feature updates, technical assistance, and on-site support.
Contract & Timeline
- Type: Sources Sought / Market Research
- Set-Aside: Total Small Business Set-Aside (FAR 19.5)
- NAICS Code: 513210 Software Publishers (Small Business Size Standard: $47.0 million)
- Anticipated Period of Performance: One-Year Base with Four-Year Options
- Response Due: June 23, 2026, by 1:00 PM Washington, DC Local Time
- Published Date: June 9, 2026
- Place of Performance: Silver Spring, MD
Response Requirements
This is a Market Research notice, not a Request for Proposal or Solicitation. The FDA is seeking information to assess industry capabilities. Responses should include:
- Business name, Unique Entity Identifier (UEI), address, and website.
- Business size status (e.g., small business, large business).
- Point of contact information.
- Descriptive literature demonstrating capabilities relevant to the required services.
- Informational pricing is encouraged.
Additional Notes
This notice is for planning purposes only and does not constitute a commitment by the Government to issue a solicitation or award a contract. Questions regarding this Sources Sought notice should be directed to Terina Hicks (terina.hicks@fda.hhs.gov) by June 18, 2026.