At GenVault, quality is more than a requirement. It is the foundation of everything we do. Our processes, facilities, and systems are designed to meet the highest industry standards, ensuring the integrity, security, and compliance of every material we store.
We proudly hold the following certifications and accreditations:
We operate in full GxP compliance, aligning our practices with internationally recognized guidelines including ISBER, WHO, and ISPE. Our operations are 21 CFR Part 11 compliant, follow USP standards and we are registered with the FDA as a Third-Party Logistics Provider (3PL) and a Human Cell and Tissue Establishment (HCT/P establishment), meeting DSCSA and HCT/P regulatory requirements for the storage and handling of Finished Good Drug Product and human tissue materials.
These recognitions reflect our unwavering commitment to excellence as a biorepository and our dedication to maintaining the trust of our clients. Every protocol, every safeguard, and every audit is part of our mission to deliver the highest quality services with complete regulatory compliance.