COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL PRODUCTS/SERVICES

(REVOLUTIONARY FAR OVERHAUL (RFO) DEVIATION)

General Information

Document Type: Combined Synopsis/Solicitation Solicitation Number: 7571TE26Q00030 Posted Date: 5/29/2026 Original Response Date: 6/4/2026 Current Response Date: 6/4/2026 Product or Service Code: 7A21- IT and Telecom - Business Application

Software (Perpetual License Software) Set Aside: Unrestricted Basis NAICS Code: 541519 Other Computer Related Services

Contracting Office Address

Office of Mission Acquisition Solutions (OMAS) Office of Acquisitions (OA) | Assistant Secretary for Financial Resources (ASFR) U.S. Department of Health and Human Services United States Department of Health and Human Services (HHS)

Description

This is a combined synopsis/solicitation for commercial products prepared in accordance with FAR 12. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued.

Solicitation number 7571TE26Q00030 is issued as a REQUEST FOR QUOTES for Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services (brand name or equal GoSilico). The solicitation is being issued on behalf of Food and Drug Administration (FDA).

Simplified procedures pursuant to FAR 12.201-1 are being utilized for this acquisition.

This acquisition is solicited on unrestricted basis. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01 or FAR Overhaul (RFO) Deviation Text.

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-12 http://www.acquisition.gov/

The associated North American Industrial Classification System (NAICS) code for this procurement is 541519, Other Computer Related Services. The product or service code is 7A21- IT and Telecom - Business Application Software (Perpetual License Software). The government will award a firm fixed price purchase order resulting from this combined synopsis/solicitation to the responsible quoter whose quote, conforming to the synopsis/solicitation, is considered lowest price technically acceptable. In order to be considered technically acceptable, the quoted items must meet the specifications in this solicitation.

All interested companies must provide QUOTATIONS for the following:

Supplies Line Item Description Quantity Unit Price Total Price

BRAND

NAME OR

EQUAL

GoSilico

Mechanistic Chromatography Modeling Software License Support and Maintenance Services

1 EACH

for 12 months

Services

See attached Requirements Document.

The period of performance is for 12 months to commence o/a June 25, 2026-June 24, 2027.

Place of Performance

Food and Drug Administration (FDA) 10903 New Hampshire Ave.

Silver Spring MD 20903

Provisions, Clauses, and Other Requirements

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services RFO

DEVIATION NOV 2025

Offerors must complete entity-level representations and certifications online in the System for Award Management (SAM) in accordance with FAR 52.204-7 RFO DEVIATION NOV 2025, System for Award Management – Registration.

The following contract clauses/provisions apply to this acquisition:

• FAR 52.212-4, Terms and Conditions–Commercial Products and Commercial Services RFO

DEVIATION NOV 2025

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_212_1 https://sam.gov/content/home https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_204_7 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_212_4

52.203-17 Contractor Employee Whistleblower Rights NOV 2023

52.204-7 System for Award Management NOV 2024

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-13 System for Award Management Maintenance OCT 2018

52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

RFO DEVIATION

NOV 2025

52.222-3 Convict Labor June 2003

52.222-36 Equal Opportunity for Workers with Disabilities JUN 2020

52.222-50 Combating Trafficking in Persons RFO DEVIATION

NOV 2025

52.222-90 Addressing DEI Discrimination by Federal Contractors APR 2026

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications

JUN 2020

52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving MAY 2024

52.229-11 Tax on Certain Foreign Procurements—Notice and Representation JUN 2020

52.232-33 Payment by Electronic Funds Transfer—System for Award Management OCT 2018

52.232-40 Providing Accelerated Payments to Small Business Subcontractors MAR 2023

52.233-3 Protest after Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.240-90 Security Prohibitions and Exclusions Representations and Certifications

RFO

DEVIATION

NOV 2025

52.240-91 Security Prohibitions and Exclusions

RFO

DEVIATION

NOV 2025

52.240-93 Basic Safeguarding of Covered Contractor Information Systems

RFO

DEVIATION

NOV 2025

52.244-6 Subcontracts for Commercial Products and Commercial Services

RFO

DEVIATION

NOV 2025

352.224-71 Confidential Information. (Deviation) (FEB 2024) (RFO DEVIATION)

352.232-71 Electronic Submission of Payment Requests (APR 2026) (RFO FAR

DEVIATION)

Electronic Submission of Payment Requests

(a) Definitions. As used in this clause - Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements in FAR 32.905(b) and the applicable Payment clause included in this contract.

• (Submission Instructions.) Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

• The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

(d) If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer's written authorization with each payment request.

(End of clause)

Submission Instructions

All QUOTERS must submit the following:

All QUOTATIONS must be sent to the Contract Specialist/Contracting Officer: Chantal Cornelius, chantal.cornelius@hhs.gov prior to requested closing date and time.

This is an open-market combined synopsis/solicitation for products as defined herein. The government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all QUOTES must include a statement regarding the terms and conditions herein as follows:

http://www.ipp.gov/ mailto:chantal.cornelius@hhs.gov

“The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

OR

“The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:”

QUOTERS must list exception(s) and rationale for the exception(s). QUOTERS that reject the terms and conditions of the solicitation may be excluded from consideration.

Submission must be received not later than 04 JUNE 2026 AT 10:00AM EASTERN DAYLIGHT TIME. Late submissions will be treated in accordance with the solicitation provision at FAR 52.212-1(c).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contract Specialist/Contracting Officer, Ms. Chantal Cornelius (chantal.cornelius@hhs.gov).

QUESTIONS ARE DUE NO LATER THAN JUNE 2, 2026 AT 10:00AM EASTERN DAYLIGHT TIME

All responsible sources may submit a QUOTATION which will be considered by the agency.

Point of Contact

PRIMARY POINT OF CONTACT:

CHANTAL CORNELIUS, HHS OMAS

Chantal.cornelius@hhs.gov

SECONDARY POINT OF CONTACT:

JESSE WEIDOW, HHS OMAS

Jesse.weidow@hhs.gov https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_212_1 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_212_1 mailto:chantal.cornelius@hhs.gov mailto:Chantal.cornelius@hhs.gov

REQUIREMENTS DOCUMENT

Mechanistic Chromatography Modeling Software

Software License Support and Maintenance Services (BRAND NAME OR EQUAL GOSILICO)

1. Background Mechanistic chromatography modeling is a sophisticated approach to understanding and predicting the behavior of chromatographic systems. This type of modeling is grounded in the fundamental principles of mass transfer and thermodynamics, and consider factors like molecular diffusion, adsorption isotherms, convection, and pore diffusion. Digital transformation and incorporating mechanistic chromatography models into downstream process development and manufacturing processes of biologics has become an increasingly important topic for the biopharmaceutical industry as it excels in predicting chromatographic behavior, allowing researchers to forecast how changes in operating conditions (like flow rate, temperature, or mobile phase composition) will affect the separation process. This predictive capability is invaluable for method development and optimization without extensive trial-and-error experimentation. In addition, the model can help in complying with regulatory standards, which demand strict control over manufacturing processes, ensuring consistent batch quality and performance. Mechanistic modeling offering insights into process variability, identifying critical quality attributes (CQAs), and critical process parameters (CPPs), and ensuring that processes consistently meet their predefined criteria. Especially when integrated with appropriate software tools, the model can help maintain comprehensive records of how each result was obtained, the parameters used, and the assumptions made, thereby ensuring traceability and reproducibility. For continuous manufacturing, which is an emerging technology, the ability to make real-time adjustments during the process is crucial to ensure product quality. Mechanistic models can predict the impact of changes in process conditions, allowing for immediate optimization, control, and ensuring consistent product quality.

Therefore, specific modeling and simulation tools are needed at FDA to investigate the impact of process parameters on product quality during process development, process characterization, and manufacturing processes.

2. Objective The objective is to purchase a new license for mechanistic chromatography modeling and simulation platform including adsorption isotherms model for different mode of chromatography, and fluid flow effects in a chromatography column.

3. Requirements The Office of Pharmaceutical Quality Research (OPQR) has a requirement to obtain a mechanistic chromatography modeling and simulation software to study emerging pharmaceutical manufacturing technologies or equal to software license. In order for a Vendor’s software to be deemed acceptable, the following salient characteristics shall be met:

3.1 Mechanistic chromatography modeling software

• Mechanistic modeling environment for conventional pharmaceutical processes including a graphical interface with drag and drop functionality.

• Streamlined modeling workflow from calibration experiments to simulation.

• Seamless lab integration through optimal linking to AKTA system and UNICORN software.

• Visual tools for easy interpretation of simulation outputs to support the fulfilment of quality by design obligation.

• Component-centric data structure enables plug and play with different methods, system parts, and columns.

• Collaboration and knowledge management shared databased within and between projects.

• Tamper-proof and back-traceable data and user management

• Simulates preparative liquid chromatography processes with a computer.

• Creates digital twins of downstream processes using mechanistic models.

• Enables increased process understanding for smarter and faster process development.

• Applies to a wide range of molecules and applications from early process development to late stage, scale-up, troubleshooting; and chemistry, manufacturing, and controls (CMC)

• Custom modeling capabilities to create user defined models.

• Parameter estimation from experimental data to support model validation.

• Global sensitivity analysis to analyze the impact of inputs, and model parameters on process outputs.

• Ability to estimate physical properties of components using only a few experiments.

• Ability to run optimization and characterization.

• Mechanistic model libraries including different adsorption isotherms that can be applied to different mode of chromatography.

• Mechanistic model libraries for membrane separation

3.2 Maintenance and Technical Support:

At minimum the contractor must:

• Delivery of software updates

• One business-day response to all software defect inquiries

• Availability of feature (level) upgrades

3.3 Training:

• Standardized 3-day training by the vendor.

• A standard license package includes the installation on one computer and one user account, but you can add more computer licenses and user accounts as you need them.

• During your chosen license period, updates and technical support are free.

4. Deliverables

Software and licensing key, Software and User Manuals or equal to in a digital copy provided on a CD, DVD or digital download. CD, DVD and hard copies of deliverables shall not be required to be returned to the Contractor.

Deliverables are delivered to the following address:

U.S Food and Drug Administration 5901 Ammendale Rd, Ste G, Beltsville, MD 20705

Schedule: Delivery shall be no later than 15 days after contract award.

Vendor is not responsible for installation of the software. FDA staff will install the software.

5. Inspection and Acceptance Criteria Working media: FDA will load the software and licensing to verify that the platform can execute example project files.

The Government shall have 30 working days to inspect and verify that the software is operational, functional and compatible with FDA server and software.

6. Terms of Use Fixed Term License: FDA shall the ability to purchase a new subscription after the original subscription expires to continue the use of the software and to gain access to technical support and product upgrades.

7. Period of Performance The period of performance is (1) year from the date of the award for software license and support services.

Base Year O/A 25 JUNE 2026-24 JUNE 2027 (AWARD WILL INCLUDE APPROPRIATE START

DATE)

8. Order Type The order type is firm-fixed-price.

9. Points of Contacts The Technical Point of Contact (TPOC) assigned to this contract is the person at the delivery location who will receive the goods, schedule and ensure proper installation, is responsible for maintaining the contract record, timely receiving of receipts, and for communicating with the Contracting Officer to ensure the vendor is meeting the requirements of the contract. The TPOC for this contract w i l l b e i d e n t i f i e d a t a w a r d .

10. Section 508 Standard Requirement Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the requirements document, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 http://www.access-board.gov/ http://www.acquisition.gov/ http://www.section508.gov/ compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Section 508 provisions apply to the content identified in this Requirements Document:

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Appropriate Scoping Requirement from Appendix A

• E207 Software (Appendix A, Application and Scoping Requirements) Appropriate Technical Performance and Technical Requirement from Appendix C

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

Per 339.203-70 Contract Clauses for Electronic and Information Technology (EIT) Acquisitions 352.239-73, Electronic and Information Technology Accessibility Notice FEB 2024 DEVIATION

(b) The contracting officer shall insert the clause at 353.239-74, Electronic and Information Technology Accessibility FEB 2024 DEVIATION