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.

How to Successfully Respond to an FDA Information Request (IR) — and Sleep Well at Night

At a Glance Why IRs Happen: The FDA often requests additional information during NDA/BLA...

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Emergency Response Regulatory Filing

How to Successfully Respond to an FDA Information Request (IR) — and Sleep Well at Night

3 Benefits of Modality Solutions Supporting Clinical Trials in Sub-Saharan Africa

Executive Summary: Modality Solutions’ involvement in sub-Saharan clinical trials brings the additional value of...

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Cold Chain Engineering Public Health CROs

3 Benefits of Modality Solutions Supporting Clinical Trials in Sub-Saharan Africa

What is a Cold Chain Consultant?

Because the pharmaceutical cold chain is a specialized area of the pharmaceutical development process,...

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Cold Chain Engineering

The No-Brainer Alternative to Real-World Shipping Tests

“You don’t know what you don’t know.” Why outsource your cold chain validation? Modality...

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Transport Sim Transport Simulation

The No-Brainer Alternative to Real-World Shipping Tests

Non-Standard Modes of Transportation for Cell & Gene Therapies | Executive Insights with Carson Dickey

Recently, while attending the Allogenic Cell Therapy Summit in Boston, MA, Carson was at...

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Cell & Gene Cold Chain Optimization Transport Sim Transport Simulation

Non-Standard Modes of Transportation for Cell & Gene Therapies | Executive Insights with Carson Dickey

Executive Insights with Rob Battista

We sat down with Rob Battista, Engineering Manager, to dive into his insights on...

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Cell & Gene Cold Chain Optimization Engineering Consulting

Elevating Local Expertise & Trial Infrastructure in Remote Locations – Ensuring Cold Chain Success

Executive Summary Conducting clinical trials in remote locations poses additional vulnerabilities. A “Boots on...

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Cold Chain Engineering Cold Chain Optimization Public Health CROs

Elevating Local Expertise & Trial Infrastructure in Remote Locations – Ensuring Cold Chain Success

How to Avoid an FDA Form 483 or a Warning Letter for Your mAb or Other Biologic

When your mAb or other biologic is moving through the Biologics License Application (BLA)...

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

How to Avoid an FDA Form 483 or a Warning Letter for Your mAb or Other Biologic

Ship, Quarantine, or Discard: A Streamlined Process and Analytical Tool Yields Better Decisions on Resolving Temperature Excursions

It’s estimated that seven out of ten pharmaceutical products in the US require temperature...

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

Ship, Quarantine, or Discard: A Streamlined Process and Analytical Tool Yields Better Decisions on Resolving Temperature Excursions

Why Cold Chain Engineering is Vital to Transporting Monoclonal Antibodies (mAbs) and Other Biologics

The global biologics market is forecast to reach $625 million by 20261, fueled by...

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Biologic Cold Chain Engineering Engineering Consulting