Global Cold Chain Validation for Fast Track Regulatory Approval.

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  • MORPHOSYS, image of MORPHOSYS logo

    How Robust Validation Planning and Transport Simulation Helped With FDA & EMA Accelerated Approval of MONJUVI™

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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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  • “Great job, it was a pleasure working with you, too! I think I may be speaking for all of us: we got more out of this project than we hoped.
    It really solidifies our delivery strategy.”

    -Cornelis ‘Niels’ Rijneveld, CSL Plasma

  • “We are very delighted to inform you the FDA has approved tafasitamab. On behalf of the whole team, we want to thank you

    for your great support. Well done!”

    -Kai Rosport, MorphoSys

  • “Modality Solutions developed the distribution validation strategy for our antibody-drug conjugate. They drafted all required protocols, supported the validations execution and finalized all reports. Modality Solutions hard work resulted in the regulatory authority approval and acceptance of the distribution validation. Team members Brian and Rachel were hard working, responsive, and dedicated to the success of this effort.”

    -Kevin Miodonski, Immunomedics

  • “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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