Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, September 16 at 2:00 PM EDT

Register Free →
logo
Get CLEATUS

This Government Contract opportunity from Department Of Health And Human Services was posted on May 22, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Lyophilization Process Modeling Software License & Delivery

Closed
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

Active Opportunities Like This One

NAICS: 511210
New
Federal
SpecView and Business Application Software Supply
Ofc Of Acqusition Grants-National

POSTED

1 day ago

DEADLINE

in 6 days
NAICS: 511210
New
Federal
AI Platform and Software Licensing
Commander

POSTED

1 day ago

DEADLINE

in 23 days
NAICS: 511210
New
SLED
CORES and EMResource Software Subscription Renewal
Department of State Health Services

POSTED

2 days ago

DEADLINE

in 12 days
NAICS: 511210
New
SLED
ZenGRC Software Subscription Provision
Technology Services

POSTED

2 days ago

DEADLINE

in 10 days
NAICS: 511210
New
SLED
Agenda Automation and Committee Management
Town Clerk

POSTED

2 days ago

DEADLINE

in 6 days
NAICS: 511210
New
Federal
PS12 Software License Provider
W6QM Micc-Fdo Ft Hood

POSTED

2 days ago

DEADLINE

in 4 days
NAICS: 511210
New
Federal
NetworkedIO (NIO) Software Licensing
W6QK Acc-Ri

POSTED

2 days ago

DEADLINE

in 5 days
NAICS: 511210
New
Federal
Lab Management Software (LMS) Provision & Licensing
260-NETWORK Contract Office 20 (36C260)

POSTED

2 days ago

DEADLINE

in 13 days
NAICS: 511210
New
Federal
Provision of DataPro 4 Standard Seat Licenses
FA9302 Aftc Pzz

POSTED

2 days ago

DEADLINE

in 3 days
NAICS: 511210
New
Federal
Tiger Dual Link Software Renewal Supply
Naval Air Warfare Center Air Division

POSTED

2 days ago

DEADLINE

in 3 days
NAICS: 511210
New
Federal
Surfcam Software Annual Maintenance
FA8571 Maintenance Contracting Afsc Pzim

POSTED

2 days ago

DEADLINE

in 9 days
NAICS: 511210
New
Federal
Surfcam Traditional 3-Axis Advanced Edition Software Lease
FA8571 Maintenance Contracting Afsc Pzim

POSTED

2 days ago

DEADLINE

in 9 days

AI Contract Overview

Show more

The contract involves the procurement and delivery of a single-user license for the gPROMS Lyophilization Modeling Toolbox. This includes comprehensive installation support, provision of digital manuals, and delivery of access credentials through either electronic or physical media. The purpose is to facilitate advanced modeling capabilities for lyophilization processes, ensuring the recipient can effectively utilize the software. Issued by the FDA Office Of Acquisitions And Grants Services under the Department of Health and Human Services, the subcontract pertains to NAICS code 511210. The place of performance is designated as Silver Spring, with the solicitation posted on May 22, 2026, and responses due by June 2, 2026. The contract emphasizes timely delivery and support to ensure seamless software deployment and operational readiness.

General Info

Procurement and delivery of gPROMS Lyophilization Toolbox license with installation support and documentation.

Agency

Department Of Health And Human Services → FDA Office Of Acquisitions And Grants ServicesView Agency

NAICS

511210 - Software PublishersView NAICS

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

This scope was carved out of FDA75F40126Q00155.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal)

AI Contract Breakdown

Uniform Contract Format

No contract breakdown available.

Cannot generate Contract Breakdown because no documents were found from this contract's source.

Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

Find active opportunities like this

Start your free trial to discover similar active contracts, track opportunities, and build proposals with AI assistance.

Organization & Contact Information

Show more
AgencyDepartment Of Health And Human Services → FDA Office Of Acquisitions And Grants Services
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acquisitions And Grants Services
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

Show more
Procurement and delivery of a single-user license for the gPROMS Lyophilization Modeling Toolbox, including installation support, digital manuals, and access credentials via electronic or physical media.

More opportunities from Department Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

Same awarding agency

NAICS: 541990
Federal
Regulatory Decision Frameworks and Predictive ModelingThe contract involves the development of AI and machine learning-driven predictive models and decision support tools aimed at enhancing regulatory decision-making processes. Leveraging both high-quality scientific data and real-world data, the objective is to improve the accuracy and efficiency of regulatory evaluations. This initiative is critical for advancing the FDA's ability to assess and manage health-related risks more effectively. This subcontract falls under the NAICS code 541990 and is managed by the FDA Office of Acquisitions and Grants Services within the Department of Health and Human Services. The work will be performed in Silver Spring, Maryland, and focuses on creating frameworks that support regulatory decisions through sophisticated data analysis and predictive modeling techniques. The contract was posted in January 2026 and seeks specialized expertise to integrate innovative technologies into regulatory workflows.
All Other Professional, Scientific, and Technical Services

POSTED

8 months ago

DEADLINE

N/A
View Details
NAICS: 541715
Federal
Clinical and Surrogate Endpoint Development for Regulatory ApprovalThis contract involves conducting research aimed at defining and validating clinical or surrogate endpoints to support regulatory submissions, with a particular focus on facilitating accelerated approval pathways. The work is designed to provide critical data that aids in meeting regulatory requirements, helping to streamline the approval process for new therapies or medical products. The subcontract, issued by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, falls under the NAICS code 541715, which typically includes research and development in the physical, engineering, and life sciences. The place of performance is located in Silver Spring, with the contract posted for potential subcontracting opportunities on January 13, 2026. The emphasis on endpoint development highlights the importance of scientific validation in advancing medical innovation through regulatory channels.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

8 months ago

DEADLINE

N/A
View Details
NAICS: 541611
Federal
Patient Preference Information (PPI) Quantification StudiesThis contract involves designing and conducting studies to measure patient preferences in clinical decision-making, with a particular focus on rare diseases. The work will employ structured survey techniques alongside statistical methodologies to quantitatively assess how patients weigh different treatment options and outcomes, providing valuable insights to inform regulatory and healthcare decisions. The contract is a subcontract managed by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, with the place of performance in Silver Spring, Maryland. The effort falls under the NAICS code 541611, which pertains to administrative management and general management consulting services. The project aims to enhance understanding of patient perspectives to support more patient-centered healthcare and regulatory processes.
Administrative Management and General Management Consulting Services

POSTED

8 months ago

DEADLINE

N/A
View Details
NAICS: 541715
Federal
Digital Health Integration and Real-World Evidence (RWE) AnalyticsThe contract focuses on the development and validation of digital health tools along with the integration of real-world data into regulatory frameworks. This involves utilizing predictive modeling and data science techniques to enhance the analysis and application of real-world evidence in healthcare settings. The work aims to support regulatory decision-making by leveraging advanced analytics to better interpret and utilize data collected outside traditional clinical trials. Awarded by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, the subcontract is classified under the NAICS code 541715, which pertains to research and development in physical, engineering, and life sciences. The place of performance is located in Silver Spring, and the contract was posted in January 2026. This initiative underscores the agency’s commitment to harnessing innovative digital technologies and data-driven methodologies to improve public health outcomes through more effective regulatory science.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

8 months ago

DEADLINE

N/A
View Details
NAICS: 541990
Federal
Botanical Drug Safety and Quality EvaluationThe contract involves conducting comprehensive analytical and preclinical studies to evaluate the safety, composition, and quality control of botanical drug products. This includes performing toxicology screenings and employing standardization methods to ensure the botanical drugs meet established safety and quality standards. The work is focused on supporting regulatory compliance and scientific validation of these products. Awarded by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, this subcontract falls under the NAICS code 541990, which pertains to specialized scientific services. The principal place of performance is located in Silver Spring, with the contract posted on January 13, 2026. The scope and nature of the contract emphasize the critical role of rigorous quality assessment for botanical drugs, contributing to public health protection and regulatory oversight.
All Other Professional, Scientific, and Technical Services

POSTED

8 months ago

DEADLINE

N/A
View Details
NAICS: 541990
Federal
Regulatory Science Research in Tobacco Product AssessmentThe contract focuses on conducting comprehensive public health research related to tobacco product use, encompassing behavioral studies, clinical observations, and analysis of policy impacts. The research aims to generate evidence that will inform and support regulatory decisions made by the FDA, ensuring that the agency’s regulatory actions are grounded in robust scientific data. It addresses multiple facets of tobacco use and its implications, which is critical for evaluating products under FDA oversight. This subcontract, issued by the FDA Office of Acquisitions and Grants Services within the Department of Health and Human Services, is identified under NAICS code 541990 and will be performed in Silver Spring. The contract prioritizes research activities that contribute to tobacco product assessment through a regulatory science lens, facilitating the FDA’s mission to protect public health. The focus on evidence-driven analysis highlights the importance of integrating behavioral, clinical, and policy-related research elements to comprehensively understand tobacco product impacts.
All Other Professional, Scientific, and Technical Services

POSTED

8 months ago

DEADLINE

N/A
View Details

Find Active Opportunities Like This

Get AI-powered intelligence on the opportunities still open

Every page of the solicitation package shredded into a compliance breakdown

AI-powered matching based on your capabilities and past performance

Competitor and incumbent history on the requirement

Automated alerts on amendments, Q&A deadlines, and award

Miguel
Hillary
Keith Deutsch
Christine

Join 650+ contractors already using CLEATUS