Cryoport Expands FDA Compliance with MVE Biological Solutions

Cryoport Strengthens Regulatory Compliance with FDA Registration

Cryoport, Inc. has made significant strides in the life sciences industry by registering all three manufacturing facilities of MVE Biological Solutions with the U.S. Food and Drug Administration (FDA). These facilities are recognized for adhering to quality standards and best practices that define the success of MVE as a leading manufacturer of high-quality cryogenic products.

Milestone Completion for MVE Biological Solutions

The three registered facilities highlight MVE's ongoing dedication to global regulatory compliance. The FDA registration also allows for the listing of MVE’s entire range of applicable cryogenic freezers and dewars. MVE sets itself apart by upholding rigorous standards that include compliance with 21 CFR Part 820 and Good Manufacturing Practices (GMP).

Commitment to Excellence

Jerrell Shelton, CEO of Cryoport, expressed pride in MVE's achievement, stating, "MVE’s achievement underscores our commitment to delivering the highest-quality and most reliable supply chain solutions for the life sciences industry. Our MVE team's dedication in providing lifesaving therapies is evident in our high standards. This FDA registration reflects our commitment to meeting and exceeding global regulatory standards."

Verification of FDA Registration

Cryoport encourages clients, customers, and partners to verify MVE's FDA registration. Interested parties can do so through the FDA's official database, or by reaching out directly to the company for assistance. Open lines of communication ensure that all stakeholders are informed about MVE's compliance status.

About Cryoport, Inc.

Cryoport, Inc. stands as a front-runner in supply chain solutions specifically tailored for cell and gene therapies. Catering to manufacturers, contract development manufacturers (CDMOs), and researchers, Cryoport delivers a comprehensive supply chain ecosystem. This ecosystem includes advanced temperature-controlled packaging, specialized bio-logistics services, and bio-storage solutions, all designed to enhance the efficiency and reliability of the supply chain.

Global Presence and Operations

With its corporate headquarters located in Nashville, the company operates across more than 50 global locations spread over 17 countries. This expansive reach facilitates the responsive supply chain systems necessary for today’s fast-paced life sciences industry.

Empowering MVE Biological Solutions

MVE Biological Solutions is recognized worldwide as a premier manufacturer of cryogenic systems, crucial for the preservation and transport of sensitive biological materials. Since its inception over six decades ago, MVE has established itself as a trusted name in cryogenic technology, preferred by biopharma firms, research institutions, and medical facilities. Their commitment to quality is evident in every product that reaches clients.

Product Distribution and Reach

With manufacturing sites in key global regions, MVE distributes its reliable cryogenic solutions to customers in 88 countries. This broad distribution network ensures that MVE remains at the forefront of innovation in cryogenic equipment.

Frequently Asked Questions

What is the significance of the FDA registration for MVE?

The FDA registration signifies that MVE’s manufacturing processes meet stringent regulatory standards, ensuring safety and quality in their cryogenic products.

How can clients verify MVE's FDA registration?

Clients can verify MVE’s FDA registration via the FDA’s official database or by contacting Cryoport directly for confirmation.

What products does MVE manufacture?

MVE manufactures a variety of cryogenic storage and shipping devices, including cryogenic freezers and dewars.

Where is Cryoport's headquarters located?

Cryoport's corporate headquarters is in Nashville, Tennessee, serving as a central hub for its global operations.

How long has MVE Biological Solutions been in operation?

MVE has been a leading manufacturer in cryogenic solutions for over 60 years, establishing a long history of innovation and trust in the industry.

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