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 16 at 2:00 PM EDT

Register Free →

Search

Top

Back to Contracts

Regulatory Affairs & Compliance Support

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 entails providing continuous regulatory affairs and compliance support specifically tailored to FDA submissions, labeling compliance, adverse event reporting, and audit readiness. The services are designed to ensure adherence to current Good Manufacturing Practices (cGMP) and Veterans Affairs (VA) regulatory requirements. This subcontract, titled "Regulatory Affairs & Compliance Support," falls under the NAICS code 541611, which pertains to administrative management and general management consulting services. Issued by the Department of Veterans Affairs through the Nac Federal Supply Schedule (36F797), the contract emphasizes maintaining regulatory compliance and preparedness for audits to facilitate smooth operations within the VA's regulatory framework. Although specific details such as the location of performance and points of contact are not disclosed, the ongoing support ensures that all regulatory submissions and compliance activities align with federal standards, thereby supporting the VA's mission-critical processes related to healthcare product regulation and safety monitoring.

General Info

Continuous regulatory support for FDA submissions, labeling, adverse events, cGMP, and VA compliance audits.

Agency

Department Of Veterans Affairs → Nac Federal Supply Schedule (36F797)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

IL

Set-Aside

NONE

Documents

This scope was carved out of 65ib.

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

View the prime solicitation

99--Eisai Inc. 651B - Drugs, Pharmaceuticals & Hematology Related Products V797P-2106D 3/1/12 to 2/28/17

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

PostedMay 26

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 Veterans Affairs → Nac Federal Supply Schedule (36F797)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Veterans Affairs → Nac Federal Supply Schedule (36F797)

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

Show more

Ongoing support for FDA submissions, labeling compliance, adverse event reporting, and audit readiness in alignment with cGMP and VA regulatory requirements.

Similar Contracts

Same NAICS industry code

Commonwealth Veteran 2030

Solicitation # BD-27-1110-1110C-1110L-131951

1110CONVD - EOVS

POSTED

about 12 hours ago

DEADLINE

in about 1 month

Construction Cost Estimator / Procurement Specialist

City of Decatur

POSTED

about 16 hours ago

DEADLINE

in about 1 month

Alberta Electric System Operator - Request for Proposal - Consultant for Reliability Standards Sync Up Implementation Program Planning and Business Design

Solicitation # AB-2026-06237

The Alberta Electric System Operator is seeking a consultant for a contract running from January 2, 2027, to December 31, 2027. The primary objective is to support the Reliability Standards Sync Up Project by developing a comprehensive Implementation Plan and Business Design Program. This initiative is designed to ensure that both the AESO and industry participants are fully prepared to comply with all applicable Alberta Reliability Standards. This solicitation, identified as AB-2026-06237, was posted on September 11, 2026, with a response deadline of October 15, 2026. The project will be performed within Alberta, and interested parties are directed to coordinate with the procurement specialist, Naomi Withers, regarding the submission process.

Alberta Electric System Operator

POSTED

about 16 hours ago

DEADLINE

in about 1 month

OH Case Management and Administrative Support

South Central Ambulance Service Nhs Foundation Trust

POSTED

about 16 hours ago

DEADLINE

Lease Administration and Strategic Implementation

The Tulalip Tribes

POSTED

about 17 hours ago

DEADLINE

RFP for Section 105(l) Lease Consulting Services

Solicitation # 290

The Tulalip Tribes is seeking proposals from qualified consulting firms to provide professional strategic, technical, and administrative support for Section 105(l) leases under the Indian Self-Determination and Education Assistance Act (ISDEAA). The primary objective is to identify, evaluate, develop, negotiate, implement, and administer leases for facilities used in federally funded Programs, Services, Functions, and Activities (PSFAs) to maximize lease compensation and build internal Tribal capacity. The project is structured into seven phases, with key deliverables including a facility inventory report, lease compensation methodologies, revenue forecast models, and a lease administration manual. The anticipated contract term is twenty-four months, with a projected execution date of November 9, 2026, and a project kickoff on November 16, 2026. Interested firms must submit electronic proposals in PDF format to Felicia Stripling by October 9, 2026. Submissions must include a technical proposal featuring at least three project examples and client references, as well as a cost proposal detailing hourly rates and a not-to-exceed amount. Selected consultants must provide proof of insurance prior to execution and adhere to all Tribal laws, policies, and strict confidentiality requirements regarding Tribal information.

The Tulalip Tribes

POSTED

about 17 hours ago

DEADLINE

Construction Management Services

OMB - PURCHASING

POSTED

about 17 hours ago

DEADLINE

in almost 5 years

Pinellas County SBE Consultants per the Consultant Competitive Negotiations Act (CCNA)

Solicitation # 26-0853-RFQ-CCNA

Pinellas County's Office of Management and Budget is establishing a pool of certified Small Business Enterprise (SBE) consultants under the Consultant Competitive Negotiations Act (CCNA). This ongoing solicitation seeks professional services in areas such as engineering, survey and mapping, architecture, landscape architecture, planning, coastal management, and construction management. The program specifically targets work assignments that do not exceed the 150,000 dollar local market threshold. To be eligible, firms must be located in Pinellas, Hillsborough, Pasco, or Manatee counties, employ no more than 50 full-time staff, and meet specific revenue caps: a three-year average of 3 million dollars for selective goods and services or 8 million dollars for construction providers. Applicants must submit a comprehensive proposal via the OpenGov portal, including an SF-330, a professional consultant certification form, SBE certification, Florida professional licenses, and a signed insurance statement. Evaluation is based on professional personnel ability and past performance, each worth 40 points, and SBE status, worth 20 points, with a minimum score of 75 required for shortlist acceptance. Selected consultants must adhere to the Pinellas County CADD Standards Manual and Kit for Survey and Civil Engineering and maintain specific insurance coverages, including 1 million dollars for professional liability and 2 million dollars for products and completed operations. While the county establishes this qualified pool, there is no guarantee of specific work assignments.

OMB - PURCHASING

POSTED

about 17 hours ago

DEADLINE

in almost 5 years

Program & Project Management (Decarbonisation)

Eastern Procurement Limited

POSTED

about 17 hours ago

DEADLINE

in about 1 month

Gypsy and Traveller Accommodation Assessment Specialist

North Devon District Council

POSTED

about 17 hours ago

DEADLINE

AI Strategic Technology Planning and Consulting

South Dakota State Government

POSTED

about 17 hours ago

DEADLINE

in about 1 month

Solicitation # BD-27-1188-PURCH-PURCH-133389

The Franklin Regional Council of Governments is soliciting proposals for a qualified consultant to perform a comprehensive EMS operational assessment covering 26 towns within Franklin County, Massachusetts. This project, identified as rfp 2026-2196, is managed by the Massachusetts Purchasing agency and will be performed in Greenfield. Interested parties must submit their responses by the deadline of October 14, 2026, at 7:00 PM. The primary point of contact for this solicitation is Laura Phelps, the Purchaser.

PURCH - Purchasing

POSTED

about 18 hours ago

DEADLINE

in about 1 month

More opportunities from Department Of Veterans Affairs → Nac Federal Supply Schedule (36F797)

Same awarding agency

Regulatory Affairs and Compliance SupportThe Regulatory Affairs and Compliance Support subcontract, posted on August 13, 2026, is issued under the Department of Veterans Affairs through the Nac Federal Supply Schedule 36F797. Classified under NAICS code 541611, the contract focuses on providing specialized administrative and technical assistance to ensure adherence to regulatory standards. The primary scope of work involves maintaining FSS compliance, preparing necessary regulatory submissions, and managing systemic changes. Additionally, the contractor is responsible for coordinating and responding to formal inquiries from the FDA to ensure all operational requirements and legal standards are met.

Administrative Management and General Management Consulting Services

POSTED

DEADLINE

Analytical Testing and Quality ControlThis subcontract for Analytical Testing and Quality Control is issued by the Department of Veterans Affairs under the Nac Federal Supply Schedule. The primary objective of the agreement is to secure third-party laboratory testing services to ensure the identity, potency, purity, and stability of both raw materials and finished products. The contract is categorized under NAICS code 541380 and was posted on August 13, 2026. It establishes a framework for rigorous quality control and analytical verification to maintain product standards throughout the manufacturing and supply process.

Testing Laboratories and Services

POSTED

DEADLINE

Cold Chain and Specialty LogisticsThis subcontract under the Nac Federal Supply Schedule for the Department of Veterans Affairs focuses on cold chain and specialty logistics. The primary objective is the transportation and warehousing of temperature-sensitive pharmaceuticals, specifically requiring strictly controlled environments for items that must be kept frozen or maintained between 2 and 8 degrees Celsius. The agreement is categorized under NAICS code 484220 and was posted on August 13, 2026. It establishes the necessary logistical framework to ensure the integrity of medical supplies through specialized handling and storage requirements to meet pharmaceutical safety standards.

Specialized Freight (except Used Goods) Trucking, Local

POSTED

DEADLINE

Packaging and Labeling ServicesThis subcontract for Packaging and Labeling Services is issued by the Department of Veterans Affairs under the Nac Federal Supply Schedule. The scope of work focuses on secondary packaging operations, specifically encompassing bottle filling, blister packing, labeling, and cartoning. A critical requirement of the contract is the implementation of serialization to ensure full compliance with the Drug Supply Chain Security Act. The project falls under NAICS code 325991 and was posted on August 13, 2026.

Custom Compounding of Purchased Resins

POSTED

DEADLINE

Finished Dosage Form Manufacturing (Tablets/Capsules)This subcontract through the Department of Veterans Affairs under the Nac Federal Supply Schedule involves the contract manufacturing of finished solid oral dosage forms. The scope of work specifically covers the production of tablets and capsules, encompassing essential pharmaceutical processes including blending, compression, encapsulation, and coating. The opportunity is categorized under NAICS code 325412 for pharmaceutical preparation manufacturing. It is listed as a subcontract with a posted date of August 13, 2026, and is managed via the federal procurement system.

Pharmaceutical Preparation Manufacturing

POSTED

DEADLINE

Active Pharmaceutical Ingredient (API) SupplyThis subcontract through the Department of Veterans Affairs involves the supply of Active Pharmaceutical Ingredients used in the formulation of finished dosage forms. These ingredients serve as critical upstream components essential for the drug manufacturing process. The contract is managed under the Nac Federal Supply Schedule and is categorized under NAICS code 325211. It was posted on August 13, 2026, to ensure the availability of bulk pharmaceutical materials necessary for producing finished medical products.

Plastics Material and Resin Manufacturing

POSTED

DEADLINE

IT Systems Integration for FSS Order FulfillmentThis subcontract focuses on the IT systems integration for FSS order fulfillment under the Department of Veterans Affairs. The primary objective is to establish seamless integration between the VA FSS ordering platform and the Wide Area Workflow (WAWF) system to facilitate efficient invoicing and delivery tracking. The scope of work includes the development of an ERP or e-commerce portal to manage these operations. Classified under NAICS code 541512, the project is managed through the Nac Federal Supply Schedule and is intended to optimize the digital infrastructure supporting government procurement and logistics.

Computer Systems Design Services

POSTED

about 1 month ago

DEADLINE

Quality Control and Analytical Testing ServicesThis subcontract for Quality Control and Analytical Testing Services is issued by the Department of Veterans Affairs under the Nac Federal Supply Schedule. The scope of work focuses on the in-process and release testing of pharmaceutical batches to ensure critical standards for potency, purity, sterility, and stability are met. Technical execution of these services involves the use of high-performance liquid chromatography, mass spectrometry, and various microbiological assays. The contract is categorized under NAICS code 541380 and was posted on August 12, 2026.

Testing Laboratories and Services

POSTED

about 1 month ago

DEADLINE

Regulatory Affairs and FDA Compliance SupportThis subcontract for Regulatory Affairs and FDA Compliance Support is issued under the Nac Federal Supply Schedule for the Department of Veterans Affairs. The primary objective of the contract is to provide comprehensive regulatory support to ensure compliance with FDA, USP, and federal procurement standards. Key responsibilities include managing detailed documentation, maintaining audit readiness, and handling necessary regulatory submissions. The engagement is categorized under NAICS code 541611 and was posted on August 12, 2026. It focuses on maintaining strict adherence to federal guidelines to support the agency's procurement and regulatory requirements.

Administrative Management and General Management Consulting Services

POSTED

about 1 month ago

DEADLINE

Cold Chain Logistics and Nationwide DistributionThis subcontract involves the cold chain logistics and nationwide distribution of pharmaceuticals for the Department of Veterans Affairs. The primary scope of work includes the temperature-controlled transportation and delivery of medical supplies to VA medical centers across the country, while also managing inventory and order fulfillment processes. The contract is categorized under NAICS code 484121 and is managed through the Nac Federal Supply Schedule. It is designed to ensure the integrity of pharmaceutical products through specialized handling and distribution networks to support healthcare delivery at VA facilities nationwide.

General Freight Trucking, Long-Distance, Truckload

POSTED

about 1 month ago

DEADLINE

Sterile Fill-Finish and Packaging ServicesThis subcontract for Sterile Fill-Finish and Packaging Services is issued by the Department of Veterans Affairs under the Nac Federal Supply Schedule. The scope of work focuses on specialized pharmaceutical manufacturing processes, specifically aseptic filling, vialing, and lyophilization. The contract also encompasses comprehensive secondary packaging services, which include labeling, serialization, and bar-coding to ensure compliance with federal tracking requirements. These activities fall under NAICS code 325412, designating the work as pharmaceutical preparation for human generics.

Pharmaceutical Preparation Manufacturing

POSTED

about 1 month ago

DEADLINE

cGMP-Compliant Pharmaceutical ManufacturingThis subcontract with the Department of Veterans Affairs, managed under the Nac Federal Supply Schedule, focuses on the formulation, synthesis, and batch production of active pharmaceutical ingredients and finished dosage forms. All manufacturing activities must be conducted in strict accordance with FDA cGMP standards to ensure pharmaceutical quality and safety. The agreement is categorized under NAICS code 325412 for pharmaceutical preparation manufacturing. It was posted on August 12, 2026, and is designed to support the production of critical medical components and finished drug products.

Pharmaceutical Preparation Manufacturing

POSTED

about 1 month ago

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 650+ contractors already using CLEATUS