LumenData helps FDA create a single source of truth for 2k+ regulatory viewers

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Challenge

Due to over 150,000 regulatory submissions, 88,000 firm registrations & listings, and 1.8 million adverse event reports, FDA faced the following concerns:

Complex regulatory landscape

Inconsistent information management

Increasing complexity of the international supply chain

Objective

Modernized data management

Granular understanding of the global drug supply chain

Solution

Design and analysis of different data domains including medicinal product, study, application, pharmaceutical product, and more

Rapid development processes to analyze data models

Outcome

Detailed and accurate view of real-life supply chain 

Updated supply model to improve data consistency 

Single source of truth for 2K+ regulatory viewers 

Implementation of data cleansing and data enrichment capabilities 

Improved approach for managing identifiers for downstream systems