FDA Adverse Event Reporting Systems Consolidation

The FDA seeks a contractor to modernize, enhance, and consolidate its enterprise‑wide adverse event reporting and product quality (AEM) system, unifying intake, processing, data migration, AI/ML document conversion, and real‑time analytics across all FDA Centers using the LifeSphere MultiVigilance platform. Offerors must submit a brief Capabilities Statement—limited to ten pages, excluding cover material—demonstrating the required experience, certifications, and past performance as outlined in the notice. The notice does not require selection among multiple topics; it simply requests one capabilities statement per respondent. This Sources Sought Notice is targeted to small‑business set‑asides (including 8(a), HUBZone, SDVOSB, WOSB) and will be used for market research only; responses are due by the date listed in the notification and must be emailed with the specified subject line.

Notice ID

ba21433882034efb8a921d1cc1ec3d4f

Solicitation Number

75F40125I00429

NAICS Code

N/A

Classification Code

N/A