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This Government Contract opportunity from Department Of Defense was posted on July 26, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Regulatory Compliance & FDA Submission Support

Closed
Federal

Contract Overview

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

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NAICS: 541611
New
SLED
OPERATIONAL EFFICIENCY ASSESSMENT
Solicitation # 26-908
The City of Augusta, Georgia, is seeking proposals under RFP 26-908 for a qualified firm to conduct a comprehensive Operational Efficiency Assessment. The primary objective of this study is to identify opportunities to improve service delivery, reduce or avoid costs, strengthen internal controls, and align staffing and technology with industry best practices. The selected consultant will perform data analysis, structural reviews of organizational spans of control, and business practice assessments across citywide functions and specific departments. Deliverables include a Project Management Plan within 45 to 90 days of the Notice to Proceed, interim updates every 30 days, written summaries of findings per phase, and a final comprehensive report featuring an implementation plan. Proposals must be submitted by October 19, 2026, in two separately sealed envelopes containing technical qualifications and a cost proposal, along with a digital copy on a USB drive. Evaluation is based on a 120-point scale covering firm experience, qualifications, project understanding, management, references, and cost, with an optional interview for short-listed firms. The contract requires the consultant to be legally registered in Georgia and maintain specific insurance coverages, including commercial general, automobile, and umbrella liability. Compliance with E-Verify and the SAVE program is mandatory, and the city emphasizes the participation of local small businesses. Payment is structured as monthly in arrears with net 30-day terms following the city's acceptance of delivered services.
City of Augusta

POSTED

1 day ago

DEADLINE

in about 1 month

AI Contract Overview

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The contract requires comprehensive regulatory consulting and documentation support to ensure compliance with FDA 880.5860, focusing on the preparation and submission of 510(k) applications, development of accurate and compliant labeling, facility registration, and readiness for Good Manufacturing Practice audits. The scope encompasses end-to-end regulatory strategy and execution to meet FDA expectations for medical devices, with an emphasis on timely and accurate submission of all required documentation to facilitate approval and market access. The contractor must demonstrate expertise in FDA regulatory processes and possess the ability to navigate complex compliance requirements within a defense medical supply context. Performance of this subcontract is designated for Groton, Connecticut, with a response deadline of August 3, 2026, and is categorized under NAICS code 541611 for management, scientific, and technical consulting services. The work is under the Department of Defense, specifically the Medical Supply Chain MD Surgical FSF, indicating a critical support role for military medical device regulatory compliance. There is no set-aside designation specified, and the subcontractor is expected to deliver full-service regulatory support without reliance on external documentation or references, ensuring all activities are executed in alignment with FDA standards and defense requirements.

General Info

Regulatory consulting for FDA 510(k) submission, labeling, facility registration, and GMP readiness for defense medical devices in Groton, CT.

Agency

Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSFView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

GROTON, CT, 06340-4905, USA

Set-Aside

NONE

Documents

This scope was carved out of SPE2DS-26-T-270C.

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

View the prime solicitation

SYRINGE AND NEEDLE, HYP

AI Contract Breakdown

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Provide regulatory consulting and documentation support for FDA 880.5860 compliance, including 510(k) submissions, labeling, registration, and GMP audit readiness.

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