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

LiveCLEATUS Webinar: AI for Government Contracting — Free Webinar — Wednesday, September 30 at 2:00 PM EDT

Register Free →

Search

Top

Back to Contracts

cGMP Compliance Remediation & Gap Closure

Active

Federal

Contract Overview

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

AI Contract Overview

Show more

The contract involves identifying and addressing compliance deficiencies within the Laboratory Information Management System (LIMS) to ensure adherence to current Good Manufacturing Practices (cGMP). Key activities include process validation, updating documentation, and making necessary system adjustments informed by a Site Process Analysis. The objective is to remediate gaps and enhance the system’s compliance posture. Issued by the National Institutes of Health under the Department of Health and Human Services, this subcontract focuses on services aligned with the NAICS code 541611, which pertains to administrative management and general management consulting services. The work is to be performed in Bethesda, Maryland, and the contract emphasizes thorough evaluation and adjustment of the LIMS system to meet strict regulatory standards, supporting the overall integrity and reliability of laboratory processes.

General Info

Address LIMS compliance gaps through validation, documentation updates, and system adjustments per cGMP standards.

Agency

Department Of Health And Human Services → National Institutes Of Health - CcView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

This scope was carved out of NOI-CC-26-001899.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Notice of Intent to Sole Source – Sterility Testing Service LIMS Project

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

PostedJan 7

subcontract

Ready to pursue this opportunity?

Start your free trial to track this contract, build proposals with AI assistance, and manage your pipeline.

Organization & Contact Information

Show more

AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health - Cc

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

Show more

Identification and resolution of compliance deficiencies in the LIMS system to meet cGMP standards, including process validation, documentation updates, and system adjustments based on Site Process Analysis findings.

Similar Contracts

Same NAICS industry code

Labor Compliance Services for Waterline Replacement Project in Hemet, CA

Solicitation # CIP 5661

Albert A. Webb Associates is seeking qualified small and disadvantaged business firms to serve as a subconsultant for the Oakland and Santa Fe Waterline Replacement project (CIP 5661) in Hemet, California. The project is funded through a U.S. Environmental Protection Agency Community Grant and is expected to span approximately 210 construction working days. The selected subconsultant will provide a Labor Standards Compliance Officer to monitor and verify contractor and subcontractor certified payrolls, conduct workforce interviews, verify federal trainee and apprenticeship requirements, and ensure compliance with both California prevailing wage laws and federal Davis-Bacon requirements. Key deliverables include documenting payroll corrections, reporting labor violations, and preparing monthly compliance reports and certifications for the City of Hemet. The subcontract award is contingent upon the selection of Albert A. Webb Associates by the City. The selected firm must comply with City contract and insurance requirements, federal flow-down provisions, and public works regulations, including 40 CFR Part 33 regarding Disadvantaged Business Enterprises. Interested firms must submit a technical proposal, a fee proposal, and documentation of their small or disadvantaged business certifications. The overall project requires strict adherence to the Build America, Buy America Act and various civil rights and nondiscrimination laws, including the Americans with Disabilities Act and Title VI of the Civil Rights Act.

Albert A. Webb Associates

POSTED

about 4 hours ago

DEADLINE

CA18488 - RFQ2026/37 - Appointment of Specialist Consultancy Team to present options regarding appropriate operating models for a new Theatre and Conference facility in Newry City.

Solicitation # 90b372e4-add0-4ba3-99b9-c05f8f28fafb

The Newry, Mourne and Down District Council is seeking a specialist consultancy team to assess and recommend the most effective operating models for a new Theatre and Conference Centre in Newry City. The primary objectives of this appointment are to ensure the long-term viability of the facility, promote artistic creativity, and successfully grow a new audience. Interested parties must access the competition through the MultiQuote portal using reference CA18488. The response deadline for this solicitation is October 7, 2026, at 11:00 AM. All queries regarding the application process should be directed to MultiQuote.

Newry, Mourne and Down District Council (NMD)

POSTED

about 6 hours ago

DEADLINE

FY27 Mentor Protege Program (MPP) Broad Agency Announcement

Solicitation # MPP-FY2027

The FY27 Mentor-Protégé Program (MPP) is a business development initiative by the Department of War designed to integrate high-capability small businesses into the Defense Industrial Base. The program pairs eligible small businesses, known as Protégés, with large prime contractors, acting as Mentors, to provide technical and business developmental assistance. Key technical priorities include modernizing IT infrastructure and cloud optimization, data integration and advanced analytics, cyber and industrial security, and digital workforce governance. Eligible Mentors must have at least 25 million dollars in Department of War contracts from the previous fiscal year and an active subcontracting plan, while Protégés must meet SBA size standards and specific socio-economic categories. The application process consists of two phases: an initial white paper submission followed by a final proposal for selected candidates. White papers are reviewed on a quarterly cycle throughout the year. Selected participants may also apply for the Protégé Pilot Initiative (PPI) to propose specific projects supporting the War Fighter, capped at 25 percent of the annual budget. Approved agreements are limited to reimbursable contracts with a maximum period of performance of 36 months. All participating vendors must maintain active registration in SAM.gov.

POSTED

about 8 hours ago

DEADLINE

Human Performance Optimization (HPO) Model

Solicitation # N4571A-26-I-0003

The Commander Navy Installations Command is conducting market research through Request for Information N4571A-26-I-0003 to transform the Morale, Welfare, and Recreation fitness program into an integrated Human Performance Optimization model. This initiative aims to shift from utilization-based programs to a performance-oriented strategy that integrates strength and conditioning, nutrition, mental resilience, and recovery protocols. The program seeks to leverage state-of-the-art technologies, including artificial intelligence, machine learning, and immersive virtual platforms, to enhance Navy readiness, optimize decision-making, and improve workforce capability. A proof-of-concept for this transformation is scheduled for implementation during Fiscal Year 2027 at Naval Base San Diego. The government is seeking industry capabilities for workforce development, data-driven evaluation frameworks, inclusive programming for diverse user groups, and secure enterprise-wide access solutions. All proposed programs must be grounded in evidence-based education and physical training methodologies and adhere to robust security and privacy protocols. This RFI is for planning purposes and does not constitute a formal request for proposal or a commitment to contract.

Commander Navy Installations Command

POSTED

about 8 hours ago

DEADLINE

GB-London: Consultancy Required for LondonEnergy Future Transport Yard Feasibility

Solicitation # BIP1068554466

LondonEnergy Ltd is seeking a qualified consultant to conduct a feasibility study and strategic options appraisal regarding its transport yard facilities. The primary objective is to determine if the current Hawley Road site can be retained or to identify a suitable replacement that meets operational requirements and provides value for money before the existing lease expires in February 2030. The appointed consultant must recommend a preferred option by June 2027 to allow sufficient time for design, procurement, environmental assessments, and construction. This project is open to small and medium enterprises, with the selection process based on specific procurement criteria. The response deadline for this solicitation is October 5, 2026.

LondonEnergy Ltd

POSTED

about 8 hours ago

DEADLINE

ON-CALL PARKING CONSULTANT SERVICES

Solicitation # ON-CALL PARKING CONSULTANT SERVICES

The City of West Hollywood is seeking proposals from qualified firms or individuals to provide on-call parking consultant services. The selected consultant will be engaged for an initial term of five years, with the possibility of a two-year extension. Interested parties must submit their proposals by the deadline of November 17, 2026, at 2:00 PM PT. Detailed bid documents and submission requirements are available through the City of West Hollywood's official public notices portal.

City of West Hollywood

POSTED

about 13 hours ago

DEADLINE

in about 2 months

Project Manager – Level 3

Solicitation # ISED216393

Innovation, Science and Economic Development Canada is seeking Project Manager Level 3 expertise under the Task-Based Informatics Professional Services framework to provide project management support for the Transformation Portfolio and Design Branch. The scope of work involves supporting IM/IT projects and initiatives for related branches, specifically benefiting Corporations Canada and the Office of the Superintendent of Bankruptcy. The proposed contract duration is two years, with an estimated level of effort of 240 days per year for up to six resources. Both the providing company and the individual resources are required to maintain Secret level security clearance. This procurement is managed by contracting authority Jessica Cadieux under solicitation number ISED216393.

Department of Industry

POSTED

about 15 hours ago

DEADLINE

Random Moment Sampling System and Title IV-E Claim Support

Solicitation # RFP JUV-27-4E-SW-004

The Iowa Judicial Branch, specifically Juvenile Court Services, is seeking a qualified respondent under solicitation RFP JUV-27-4E-SW-004 to provide comprehensive support for Title IV-E claiming. The selected provider will be responsible for delivering expert consultation and technical assistance across administrative, prevention, and training services. A primary requirement of the contract is the configuration, implementation, and maintenance of a web-based Random Moment Sampling (RMS) system to manage administrative claiming, alongside the delivery of scheduled and on-demand reporting. The scope of work includes quarterly evaluations of program and activity coding to enhance claiming processes, quality assurance activities, and technical support during audits. Additionally, the respondent must develop training programs for new users and participate in quarterly virtual meetings to analyze data trends and identify areas for improvement. Interested parties must submit their responses by October 31, 2026, to the primary point of contact, Angi Hillers.

POSTED

DEADLINE

in about 1 month

JFS-OWD-Accenture EV Workforce-A7

Solicitation # CTR024105-A6

The Job And Family Services agency in Ohio has issued solicitation CTR024105-A6 for strategic planning consultation services regarding the EV Workforce. This project, titled JFS-OWD-Accenture EV Workforce-A7, is managed by the state of Ohio under the SLED organization type. The solicitation was posted on September 21, 2026, with a response deadline set for June 30, 2027. Performance of the contract will take place within the state of Ohio, and Norwood Anthony serves as the primary point of contact for the procurement process.

Job And Family Services

POSTED

DEADLINE

Educational Technology/STEM Specialist ConsultantThis subcontract opportunity is for an Educational Technology/STEM Specialist Consultant to provide expert design input for STEM learning environments within the Savannah/Chatham County Public School System. The consultant will support prime contractors by designing specialized laboratories and maker spaces, integrating STEM-specific technology infrastructure, and developing detailed equipment lists and space utilization plans. The solicitation was posted on September 21, 2026, with a response deadline of October 22, 2026. Falling under NAICS code 541611, this role focuses on delivering technical expertise to ensure educational facilities are optimized for modern science, technology, engineering, and mathematics instruction.

Savannah/chatham County Public School System

POSTED

DEADLINE

Project Controls & SchedulingThe Project Controls and Scheduling subcontract, issued by Kiewit Infrastructure West Co., seeks a provider to perform professional project scheduling and Critical Path Method analysis for power construction projects. The selected contractor will be responsible for delivering detailed project schedules and CPM analysis reports to support prime contractors. To be eligible, applicants must hold a valid California Contractor's license and provide 100 percent bonding. This opportunity is designated as an SBA set-aside, welcoming applications from Small Businesses, Small Disadvantaged Businesses, Women-Owned Small Businesses, HUBZone Small Businesses, Veteran-Owned Small Businesses, and Disadvantaged Business Enterprises. The solicitation was posted on September 21, 2026, with a response deadline of September 30, 2026. The contract falls under NAICS code 541611.

Kiewit Infrastructure West Co.

POSTED

DEADLINE

Regulatory Reform Consultant (Terms of Reference Development)The Government of Jamaica is seeking a Regulatory Reform Consultant to support the ICT Authority in developing formal Terms of Reference and proposed reforms for prime contractors. The selected consultant will be responsible for translating market analysis findings into actionable policy reforms and drafting technical documentation for implementation. This role requires a strong background in procurement and general management consultancy to ensure that the resulting frameworks are technically sound and aligned with organizational goals. The primary objective of this subcontract is the delivery of formal TOR documents specifically focused on proposing reforms for Digital Financial Services accessibility. Candidates must possess demonstrated experience in procurement and financial management consultancy to successfully execute these deliverables. The project is categorized under NAICS code 541611, reflecting its focus on administrative and general management consulting services.

ICT Authority (formerly eGov)

POSTED

DEADLINE

More opportunities from Department Of Health And Human Services → National Institutes Of Health - Cc

Same awarding agency

Notice of Intent to Sole Source – Adaptive Biotechnologies Corporation

Solicitation # 26-010014

The National Institutes of Health Clinical Center intends to award a firm fixed price sole source contract to Adaptive Biotechnologies Corporation for specialized reference laboratory testing services. This acquisition focuses on the proprietary clonoSEQ Assay to provide Minimal Residual Disease testing for immunocompromised patients and those with advanced hematologic malignancies, as the Department of Laboratory Medicine currently lacks the necessary in-house equipment and reagents. The procurement is being conducted under FAR Part 13 Simplified Acquisition Procedures, as Adaptive Biotechnologies Corporation is identified as the only available source for these specific services. The place of performance is Bethesda, Maryland, under NAICS code 339112. This action is a notice of intent rather than a request for quotation, and interested parties must submit their capabilities to the NIH Clinical Center by September 25, 2026.

Surgical and Medical Instrument Manufacturing

POSTED

about 8 hours ago

DEADLINE

Cloverleaf Software Maintenance & Technical Support

Computer Facilities Management Services

POSTED

DEADLINE

Cloverleaf Security Server maintenance and support - Bethesda Site (Notice of Intent to sole source)

Solicitation # NOI-26-008015

The National Institutes of Health Clinical Center, Department of Clinical Research Informatics, intends to negotiate a sole source contract with Infor LLC for maintenance and support of the Cloverleaf Security Server at the Bethesda, Maryland site. This mission critical system provides essential encryption for the HL7 interface engine, which serves as the primary link between the Clinical Research Information System and various ancillary systems, including laboratory and radiology information systems. Because the software is proprietary to Infor and critical for the safe delivery of patient care and the protection of personally identifiable information, the government has determined that Infor is the only responsible source capable of providing the necessary maintenance and source code revisions. The period of performance is scheduled from September 26, 2026, to September 25, 2027. The scope of work includes the provision of no-cost application updates, email notifications for updates, 24x7 remote telephone technical support, and access to a 24x7 web knowledge base. Additionally, the contractor must maintain an established escalation process for critical issues. All deliverables must be marked with the date, offeror name, and task order details, with final inspection and acceptance conducted by the Contracting Officer's Representative at the NIH facility in Bethesda.

Software Publishers

POSTED

DEADLINE

Records Management and Retrieval ServicesThis contract involves the ongoing management of stored physical film records for the National Institutes of Health in Bethesda, focusing on comprehensive indexing, retrieval, and secure return processes. It integrates digital tracking systems to ensure efficient handling and accurate recordkeeping throughout the service lifecycle. The contract falls under NAICS code 561400, which pertains to administrative and support services, and is structured as a subcontract arrangement with the Department of Health and Human Services. The scope emphasizes secure handling procedures to maintain the integrity and confidentiality of records during storage and retrieval. The services are designed to support the agency’s operational needs by providing reliable access to physical films on request, backed by digital advancements that enhance tracking and management capabilities. The contract was posted in mid-January 2026 and is positioned to support NIH’s ongoing information management infrastructure at its Bethesda facility.

POSTED

DEADLINE

Secure Shredding and Destruction of Sensitive MaterialsThis contract involves the secure shredding and destruction of sensitive patient-related materials, including physical film records and documentation. It emphasizes strict adherence to chain-of-custody protocols to ensure the integrity and confidentiality of the materials throughout the process. The contract mandates secure transport and certified destruction methods that comply with applicable privacy regulations, ensuring that all sensitive information is handled and disposed of in a manner that protects patient privacy. The subcontract is issued by the National Institutes of Health, under the Department of Health and Human Services, with the place of performance located in Bethesda, zip code 20892. The chosen NAICS code for this contract is 561990, which relates to specialized waste management services. This contract highlights the importance of regulatory compliance and secure handling procedures in managing sensitive healthcare materials for a federal health agency.

All Other Support Services

POSTED

DEADLINE

Secure Physical Records StorageThis contract involves the long-term storage of over 14,000 linear feet of physical film records that contain sensitive patient information. The storage is required to be climate-controlled to ensure preservation and security of the materials. The scope includes comprehensive inventory management and secure access controls to maintain confidentiality and integrity of the records. The work is performed in Bethesda, with the National Institutes of Health, under the Department of Health and Human Services, overseeing the subcontract. The contract falls under the NAICS code 493110, which pertains to general warehousing and storage services. It was posted on January 16, 2026, and requires adherence to strict security and environmental control standards appropriate for sensitive health-related data. The emphasis is on maintaining secure, organized, and controlled storage to support ongoing compliance with regulatory requirements concerning patient information.

General Warehousing and Storage

POSTED

DEADLINE

LIMS Software Maintenance and SupportThis subcontract, titled LIMS Software Maintenance and Support, is issued by the National Institutes of Health Clinical Center under the Department of Health and Human Services. The primary objective is to provide ongoing maintenance, updates, and technical support for the proprietary Laboratory Information Management System used by prime contractors. Specifically, the contract focuses on ensuring system stability and functionality for the PET department through the delivery of a fully maintained and active software environment. The project is based in Bethesda, Maryland, and falls under NAICS code 541511. The solicitation was posted on January 12, 2026, with a response deadline set for November 5, 2026.

Custom Computer Programming Services

POSTED

DEADLINE

in about 1 month

ASIT.TO 1 year software support from ArgonSoft (Notice of Intent to sole source)

Solicitation # NOI-CC-26-000808

The National Institutes of Health Clinical Center intends to award a firm-fixed-price sole source contract to ArgonSoft for a 12-month software maintenance agreement for the ASIS.TO Laboratory Information Management System (LIMS) used by the PET Department. The period of performance is scheduled from January 1, 2026, to December 31, 2026. Because ArgonSoft is the creator and license holder of the proprietary software, they are identified as the only responsible source capable of providing the required customized support. The scope of work includes gold-level support consisting of up to 200 man-hours of remote technical assistance delivered via phone, email, video chat, and an online helpdesk. Key deliverables include the installation of mandatory updates, minor upgrade packages, bug fixes, and installation and operation qualification tests. Additionally, the agreement covers consultancy for system configuration, new workflow definition, performance qualification support, and system customizations, including EQonn plugin modifications. Performance will be managed remotely for the NIH Clinical Center located in Bethesda, Maryland.

Software Publishers

POSTED

DEADLINE

in about 1 month

Sterility Testing Service (STS) Workflow OptimizationThe contract focuses on enhancing the operational efficiency of the Sterility Testing Service unit by conducting process analysis and implementing system adjustments within the Laboratory Information Management System (LIMS) Portal. Key elements include workflow automation to streamline processes, improvements in reporting capabilities to facilitate better data management, and comprehensive training for users to ensure effective adoption of the updated system. The objective is to optimize the sterility testing workflows to support higher productivity and accuracy. This subcontract is issued by the National Institutes of Health under the Department of Health and Human Services, with performance located in Bethesda. It falls under the NAICS code 541618, which relates to other management consulting services. The contract serves as a critical initiative to modernize the Sterility Testing Service unit’s operations, ensuring that technological and procedural enhancements align with organizational goals for quality and efficiency.

Other Management Consulting Services

POSTED

DEADLINE

LIMS Portal Licensing & Access ManagementThis contract involves the implementation and management of user licenses for a Portal within the Laboratory Information Management System (LIMS) environment. The scope includes establishing role-based access control, provisioning users, and tracking licenses to ensure efficient and secure access to the system. The effort is designed to support the organization’s need to regulate and monitor user interactions within the LIMS platform. Awarded as a subcontract under the NAICS code 518210, the contract is associated with the National Institutes of Health, under the Department of Health and Human Services. The place of performance is Bethesda, with a postal code of 20892. The contract was posted on January 7, 2026, and addresses critical aspects of license management and access security to optimize user administration within the LIMS infrastructure.

Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services

POSTED

DEADLINE

LIMS Portal Configuration & RolloutThis contract involves the configuration and deployment of the Portal component within an existing commercial off-the-shelf (COTS) Laboratory Information Management System (LIMS) that adheres to current Good Manufacturing Practices (cGMP). The work includes system setup, the configuration of user access, integration of workflows, and providing support during the rollout phase to ensure smooth implementation. The contract is a subcontract awarded by the National Institutes of Health's Center for Cancer Research under the Department of Health and Human Services. The place of performance is Bethesda, Maryland, with a specified ZIP code of 20892. The contract focuses on information technology services categorized under NAICS code 541512, which pertains to computer systems design services. The arrangement aims to enhance the functionality and usability of the LIMS Portal, supporting compliance requirements and streamlining laboratory operations within a regulated environment. The solicitation does not list a specific solicitation number or set-aside status.

Computer Systems Design Services

POSTED

DEADLINE

Parts and Component Supply (Proprietary)This contract involves the supply of all replacement parts, consumables, and upgraded components necessary for maintenance or repair under the all-inclusive SL3 service plan. It is designated as a subcontract and falls under the NAICS code 423490, which pertains to professional and commercial equipment and supplies merchant wholesalers. The contracting agency is the National Institutes of Health, part of the Department of Health and Human Services, with the place of performance specified as Bethesda, Maryland. The contract ensures continuous support for the SL3 service plan by providing timely access to proprietary parts and components required for equipment upkeep. While some specific details such as solicitation number and type of set-aside are not provided, the subcontract emphasizes a focus on maintaining operational readiness through reliable parts supply. The location and agency information confirm that this contract serves a federal health-related institution, emphasizing the importance of quality and compliance in servicing critical medical or research equipment.

Other Professional Equipment and Supplies Merchant Wholesalers

POSTED

DEADLINE

Ready to Pursue This Opportunity?

Get AI-powered intelligence on this solicitation and the ones like it

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

Join 750+ contractors already using CLEATUS