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Embleema

Metuchen, New Jersey, United States

Ownership: Private
Development stage: Other

Overview

Embleema is not a therapeutic developer and has no drug clinical trials; instead it provides a regulatory-grade data and analytics platform used for observational, Phase IV and non‑interventional studies, registries, and genomic/biomarker analyses, including use by FDA and life science sponsors.[1][2][5]

Industry: Biomedical IT and Biomedical Data Platforms

Partnerships

U.S. Food and Drug Administration (FDA) – HIVE platform used since 2013 for regulatory decisions and research, including genomic analysis of viral vectors and vaccines and ARGOS microbial pathogen sequencing project[2]FDA Office of Vaccines Research and Review – uses HIVE to analyze viral vector products and vaccine batches[2]Department of Defense (U.S. Navy bases, wastewater surveillance for infections/bioattack indicators)[6]Pharmaceutical companies and biotechs using HIVE and Embleema platforms for regulatory submissions and real‑world evidence generation[1][2][5]Patient advocacy groups and clinical research centers for registries and observational studies[1][2]AgeTech Collaborative from AARP – startup program participant[6]

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