Embleema
We provide regulatory bioinformatics expertise and software for cell and gene therapy products. Our HIVE bioinformatics platform is used by the U.S. Food and Drug Administration for its regulatory review of -omics based health products. When cell and gene therapy companies use our HIVE platform, they accelerate or unlock their FDA approvals for INDs, BLAs or NDAs. We are also CDISC's partner to define evidence generation standards for cell and gene therapies.