Biopharma Cold Chain Resources

Whether you’re new to cold chain regulatory requirements or a seasoned expert in shipping validations, Modality Solutions offers expert perspectives on the biopharmaceutical cold chain industry.

Regulatory Filing

Regenerative Medicine – A Catalyst for Modern Targeted Cancer Therapy

For thousands of years, tissue regeneration has been a topic of interest among the...

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Cell & Gene Emergency Response Regulatory Filing

Regenerative Medicine – A Catalyst for Modern Targeted Cancer Therapy

Why Traditional Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

Temperature data loggers have been around for decades and were one of the first...

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Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

Why Traditional Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

4 Challenges in Immunotherapy Drug Supply Chains and Logistics

Immunotherapy, the process of strengthening a patient’s own immune system using pharmaceuticals, is rapidly...

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Cell & Gene Cold Chain Engineering Regulatory Filing

4 Challenges in Immunotherapy Drug Supply Chains and Logistics

Blockchain Applications in Pharmaceutical Serialization

While blockchain is typically associated with bitcoin or other cryptocurrencies, it is actually a...

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Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

Blockchain Applications in Pharmaceutical Serialization

It Is Never Too Late to Document Your Cold Chain Process Validation Approach

Documentation strategy for your cold chain management validation practices has evolved over the last...

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Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

It Is Never Too Late to Document Your Cold Chain Process Validation Approach

Why Is Pharmaceutical Transportation a Major Concern?

First published on May 11, 2015 on Cold Chain IQ – as a contributor,...

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Biologic Cell & Gene Drug-Device Combo Products Emergency Response Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

Why Is Pharmaceutical Transportation a Major Concern?

Pharmaceutical Cold Chain Is Complex

First published on April 9, 2015 on Cold Chain IQ – as a contributor,...

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Biologic Cell & Gene Cold Chain Engineering Cold Chain Optimization Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

Three Departments Working Together for Cold Chain Success

How do you go about integrating your cold chain and what is involved? To...

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Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

Three Departments Working Together for Cold Chain Success

Every Quality Agreement Needs A Great Investigative Reporter

Admit it – We all wanted to be great investigative reporters like Bob Woodward...

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Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

Every Quality Agreement Needs A Great Investigative Reporter

Integrate cold chain management systems?

“We integrate cold chain management systems.” I was struggling for a ‘tag line’ for...

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Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers