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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