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.

Modality Solutions’ New Greenwood Lab Slashes Lead Times and Expands Testing

Modality Solutions is proud to announce the launch of our new Greenwood Lab—a state-of-the-art...

read Details

Press Release

Modality Solutions’ New Greenwood Lab Slashes Lead Times and Expands Testing

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...

read Details

Emergency Response Regulatory Filing

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

Reliable Partnerships and Regulatory Assurance: The Backbone of Biopharma Logistics

In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...

read Details

Biologic Cell & Gene Cold Chain Engineering Cold Chain Optimization Drug-Device Combo Products Emerging BioPharma Engineering Consulting Pharmaceutical Regulatory Filing Transport Sim Transport Simulation

Reliable Partnerships and Regulatory Assurance: The Backbone of Biopharma Logistics

A Cold Chain Process Validation Guide: Part 6: Performance Qualification (PQ)

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

read Details

Biologic Cold Chain Engineering Emerging BioPharma Engineering Consulting Pharmaceutical Regulatory Filing Transport Simulation

A Cold Chain Process Validation Guide: Part 6: Performance Qualification (PQ)

Unlocking FDA Insights: Open Data Files for Successful BLA Submissions

Are you aware of the open data files published online by the FDA? This...

read Details

Biologic Cold Chain Engineering Emerging BioPharma Engineering Consulting Pharmaceutical Regulatory Filing Transport Sim Transport Simulation

Unlocking FDA Insights: Open Data Files for Successful BLA Submissions

A Cold Chain Process Validation Guide: Part 5: Operational Qualification (OQ) for Drug Products

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

read Details

Biologic Cold Chain Engineering Cold Chain Optimization Emerging BioPharma Engineering Consulting Pharmaceutical Regulatory Filing Transport Simulation

A Cold Chain Process Validation Guide: Part 5: Operational Qualification (OQ) for Drug Products

A Cold Chain Process Validation Guide: Part 4: Component Qualification / Installment Qualification (CQ/IQ)

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

read Details

Biologic Cold Chain Engineering Cold Chain Optimization Emerging BioPharma Engineering Consulting Pharmaceutical Regulatory Filing Transport Simulation

A Cold Chain Process Validation Guide: Part 4: Component Qualification / Installment Qualification (CQ/IQ)

A Cold Chain Process Validation Guide: Part 3: Developing Mature Quality Systems

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

read Details

Biologic Cold Chain Engineering Cold Chain Optimization Emerging BioPharma Engineering Consulting Pharmaceutical Regulatory Filing Transport Simulation

A Cold Chain Process Validation Guide: Part 3: Developing Mature Quality Systems

Unlocking FDA Insights: Exploring Open Data Files for Shipping Validation

Are you aware of the open data files published online by the FDA? This...

read Details

Cold Chain Engineering Cold Chain Optimization Engineering Consulting Pharmaceutical Transport Sim Transport Simulation

Unlocking FDA Insights: Exploring Open Data Files for Shipping Validation

A Cold Chain Process Validation Guide: Part 2: Integrating your Cold Chain Management Systems

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

read Details

Biologic Cold Chain Engineering Cold Chain Optimization Emerging BioPharma Engineering Consulting Pharmaceutical Regulatory Filing Transport Simulation