This Combined Synopsis/Solicitation opportunity from Department Of Defense was posted on April 10, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Food and Drug Administration (FDA) Regulatory Compliance Training

Closed

HT9425-25-R-0050Federal

Submission Closed04/18/2025, 06:00:00 PM UTC

Contract Overview

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

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NAICS: 541990

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Solicitation # BD-27-1271-CPO00-CPO-134416

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CPO001 - Town of Franklin Purchasing Department

POSTED

2 days ago

DEADLINE

in 19 days

AI Contract Overview

This contract involves providing comprehensive competency training for personnel engaged in FDA-regulated research activities within the USAMRDC. The training focuses on key regulatory areas such as Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Systems Regulations (QSR). The overarching goal is to ensure that staff involved in the development of FDA-approved pharmaceuticals, devices, or biologics maintain the necessary education, training, and experience to comply with federal regulations outlined in 21 CFR parts 50, 58, 211, 600, and 820. The USAMRDC emphasizes the importance of a robust compliance program, with the USAMRDC Headquarters Principal Acquisition Assistant acting as the sponsor representative responsible for overseeing FDA-related responsibilities and training efforts across subordinate commands. The USAMRDC Office of Research and Acquisition (ORA) will provide technical oversight, guidance, and management of the training initiative. The primary objective of this contract is to support personnel involved in FDA-regulated product development in maintaining their competency and ensuring adherence to applicable regulations and directives. This initiative aims to foster ongoing compliance and competence in GCP, GLP, and cGMP practices, ultimately supporting the USAMRDC’s mission to deliver FDA-approved products to the U.S. Military. The solicitation, posted on April 10, 2025, under the total small business set-aside category, invites responses by April 18, 2025. The contract will be managed by the Army Medical Resources Acquisition Activity, based in Fort Detrick, Maryland, with the performance location in Frederick, MD. The designated point of contact is Matthew Gembe, reachable via email or phone for further information.

General Info

FDA Regulatory Compliance Training contract for small businesses; response due April 18, 2025.

Agency

Department Of Defense → Army Medical Resources Acq Activity

NAICS

541990 - All Other Professional, Scientific, and Technical Services

Place of Performance

Frederick, MD, 21702, USA

Set-Aside

SBA

Documents

Attachment 3: Past Performance References

past-performance

High

B08+Attachment+1+-+Non-Disclosure+Agreement.docx

B08+Attachment+2+-+Organizational+Conflict+of+Interest+Certification+Form.docx

B08.+HT9425-25-R-0050%2BRFP+Amendment+0001.docx

B08+Pricing+Sheet+-+Attachment+4.xlsx

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

CLEATUS splits the solicitation into Uniform Contract Format (UCF) sections: scope, pricing, deliverables, and evaluation criteria.

Timeline

1 update

PhaseClosed

PostedMar 27

Combined Synopsis

Notice updatedApr 10

Notice details unchanged. Attachments may have changed.

Response DeadlineApr 18

Deadline has passed

Submission Closed

04/18/2025, 06:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Defense → Army Medical Resources Acq Activity

Contacts1 person available

OfficeFORT DETRICK, MD, 21702, USA

Organization / AgencyDepartment Of Defense → Army Medical Resources Acq Activity

Office AddressFORT DETRICK, MD, 21702, USA

Contacts

Matthew Gembe

contact@example.gov

+1 (555) 000-0000

Full Description

This requirement provides competency training for personnel involved in FDA regulated research activities. The USAMRDC requires FDA regulated training in the areas of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Systems Regulations (QSR). Background: The purpose of USAMRDC research and development activities is to provide FDA-approved pharmaceuticals and devices or licensed biologics to members of the United States (U.S) Military. These activities are governed by Federal, Department of Defense (DoD), and Army regulation and result in submissions to the FDA for eventual approval or licensure. Those research and development activities are subject to the compliance requirements of the FDA. The requirements defined in Title 21, Code of Federal Regulations (21 CFR), parts 50, 58, 211, 600, and 820, require all individuals engaged in the conduct or supervision of FDA-regulated studies have education, training, and experience, or a combination thereof, to enable the individual to perform the assigned functions. Therefore, the Command must have in place, as part of its Quality efforts, a compliance program that includes minimum standards for training of all personnel involved in FDA-regulated activities. Training requirements are outlined in accordance with USAMRDC Command Policy Memorandum 2013-60 Requirement for Training of Personnel Involved in FDA-Regulated Activities. The USAMRDC Headquarters Principal Acquisition Assistant serves as the FDA regulated Sponsor Representative, the responsibility for fulfilling FDA regulated sponsor responsibilities, and providing this training for other Subordinate Commands. USAMRDC ORA will provide technical oversight, guidance, and management of this requirement. Objective: Assist personnel involved in FDA regulated product development throughout USAMRDC in maintaining competency in GCP, GLP, and cGMP to comply with U.S FDA and all other applicable DoD and Army regulations, directives, and guidance. The long-term objective of this training is to increase and maintain competency and compliance with FDA regulations governing product development efforts to meet our mission.