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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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  • Update and streamline your thermal packaging qualification processes to ensure compliance and efficiency.

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  • Gain approval of a biosimilar cold chain thru proper design and execution of cold chain process validation.

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  • “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

  • “An assessment of our cold chain management practices really identified some much-needed areas for improvement. The changes put in place were common-sense practical and effective. After implementation, their on-going role in day-to-day program management of our R&D cold chain was helpful.”

    -Tom Pack, Janssen Pharmaceuticals

  • “As a pure-play biosimilar, we needed guidance and execution assistance for one of the first ever FDA biosimilar filings. We engaged them 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 Process Validation Guide

A new guide to support your cold chain regulatory requirements. Get solutions that deliver valuable insights into validating an integrated cold chain while enhancing your regulatory reputation.

 

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