IPHASE Has Completed This Year’s FDA Blood Establishment Registration!

 IPHASE Completes FDA Blood Establishment Registration to Support Biopharma Excellence

IPHASE is proud to announce the successful completion of this year's FDA Blood Establishment Registration, reinforcing our commitment to regulatory compliance, quality, and biopharma-ready operations.

Under FDA regulations (21 CFR 607), establishments involved in the manufacture of blood and blood-derived products are required to register with the agency and list applicable products. This registration confirms that our facility meets FDA requirements for the manufacture and handling of blood and blood-derived products. For biopharmaceutical partners, this translates into confidence in the quality, traceability, and regulatory robustness of the biomatrix materials supporting preclinical research, assay development, and downstream applications.

At IPHASE, compliance is built into every step of our process. We remain dedicated to delivering consistent, reliable, and high-quality biomatrix solutions that help biopharma teams move faster—from discovery through development—while meeting evolving regulatory expectations.