Embleema is a company that provides a software platform for precision medicine. Their platform collects and generates regulatory-grade evidence, which is used by the FDA for evaluating health products involving genomic datasets. It is also the basis for future CDISC standards for cell and gene therapies. The platform, called HIVE, helps life sciences companies align their bioinformatics submission with the FDA, speeding up the regulatory decision-making process. The FDA also uses the platform for producing regulatory-grade genomic sequences for SARS-CoV-2 and other microbial pathogens. Embleema's platform is used by leading pharmaceutical companies, biotechs, patient advocacy groups, and clinical research centers.