BIOPHARMACEUTICAL COLD CHAIN ENGINEERING

Global Cold Chain Validation for Fast Track Regulatory Approval.

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Learn how we helped these companies

  • Validate equipment, processes & partners in a global ocean shipping process to ensure drug product quality.

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  • Identifying and implementing a revised frozen logistics process to transport palletized clinical trial material as ‘turnkey’ solution.

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  • Meeting the FDA and other international regulations regarding best practices associated with storage, distribution, monitoring & controls, and documentation.

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  • “Success! ANVISA accepted our proposal for concurrent PQ shipments! What a huge win! Again, thank you for helping us have such a robust plan and data.”

    -Judi Zylstra, Lundbeck

  • “Their integrated team approach brought immediate benefits to my team by augmenting our skills on several project teams simultaneously. They were valued members of the team the first day on the job!”

    -Michael Broughton, Eli Lilly

  • “Modality Solutions offers deep expertise in the area of logistics validation. They were instrumental in delivering our cold chain validation during launch and went above and beyond to accommodate short timelines. The folks at Modality Solutions are collaborative, responsive, and it’s a pleasure to work with everyone on the team.”

    -Amelia Milani, Achaogen, Inc.

  • “As a pure-play biosimilar, we needed guidance and execution assistance for one of the first ever FDA biosimilar filings. We engaged Modality Solutions to help us get our cold chain ready to file. We wanted to make sure we got it right, so we called the best. Their experience & expertise was invaluable.”

    -Jamie Hnaihen, Adello Biologics

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COLD CHAIN VALIDATION

Learn how to successfully integrate and validate your biopharmaceutical cold chain including immunotherapies. Get solutions and valuable insights in how to enhance your regulatory reputation.

 

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