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Regulatory Compliance & Quality Assurance (QA) Support

Active
Federal

Contract Overview

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

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The contract requires strict adherence to FDA, DEA, and DLA quality standards for pharmaceutical delivery, with an emphasis on full lot traceability, mandatory certificates of analysis, and a zero tolerance policy for any variance in product quality or documentation. All activities must ensure regulatory compliance throughout the supply chain, with no room for deviation in handling, testing, or reporting procedures. The subcontractor is expected to implement rigorous quality assurance protocols to guarantee that every pharmaceutical shipment meets the exacting requirements set forth by federal regulatory bodies and the Defense Logistics Agency. Performance is bound to the specifications of the Department of Defense and centered on maintaining the integrity of pharmaceutical logistics under the NAICS code 541690, which covers other scientific and technical consulting services. The work is tied to contract SPE2DX25D9900 and delivery order SPE2DP26F8701, and although the specific location of performance is not detailed, the requirements apply universally across all operational contexts. Compliance is non-negotiable, and failure to meet these standards could result in immediate contract breach, making precision, documentation, and accountability the foundation of all tasks performed under this agreement.

General Info

Strict FDA, DEA, DLA compliance required with zero tolerance for quality variances and full lot traceability.

Agency

Department Of Defense → Defense Logistics AgencyView Agency

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of SPE2DP26F8701.

The full solicitation package (3 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

MELOXICAM TABLETS

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Timeline

Posted

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Organization & Contact Information

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AgencyDepartment Of Defense → Defense Logistics Agency
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → Defense Logistics Agency
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Ensure compliance with FDA, DEA, and DLA quality standards including lot traceability, COAs, and zero variance tolerance for pharmaceutical delivery.

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