- Country: USA
- Summary: FDA Adverse Event Reporting Systems Consolidation
- UST Ref No: 125931863
- Deadline: 15 Sep 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 75F40125I00429
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- Description:
- Description
Purpose:
The U.S. Food and Drug Administration (FDA) of the Department of Health and Human Services (DHHS) is issuing this Sources Sought Notice (SSN) as a means of conducting market research pursusant to Federal Acquisition Regulation (FAR Part 10) to identify potential qualified small business vendors, including 8(a), HUBZone, SDVOSB, WOSB, and other socio-economic small businesses, that have the capability and relevant experience to support to need described herein. This is not a solicitation or request for proposal. The information received in response to this notice will be used for planning purposes only.
Description:
The FDA contemplates the award of a single contract to modernize, enhance and expand an existing adverse event reporting (AER) and product quality (PQ) system capability primarily used by the Center for Drug Evaluation and Research (CDER), to support the same and similar requirements for the broader enterprise, inclusive of the Center for Tobacco Products (CTP), Center for Veterinary Medicine (CVM), Center for Devices and Radiological Health (CDRH), Human Foods Program (HFP), and Center for Biologics Evaluation and Research (CBER). The new modernized FDA Adverse Event Management (AEM) represents a consolidation of multiple disparate systems, functions and contracts supporting mission critical AER and PQ capabilities across the FDA-s IT infrastructure.
This consolidation represents a strategic decision to streamline operations and improve the delivery of integrally related IT infrastructure and service delivery models, fundamental to FDA-s core mission. The initial analysis of this consolidation indicates significant benefits to the FDA through unified planning, coordination, and execution of adverse event reporting requirements, resulting in improved end user experiences, reduced administrative overhead, and strengthened IT infrastructure stability and security. Additionally, given the scale of AEM, opportunities ... - Documents:
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CLICK HERE TO LOGINFDA Adverse Event Reporting Systems Consolidation - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION, a Government sector organization in USA, has announced a new tender for FDA Adverse Event Reporting Systems Consolidation. This tender is published on USARFP under UST Ref No: 125931863 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-09-15.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
