A Cold Chain Process Validation Guide: Part 3: Developing Mature Quality Systems
Developing mature quality systems is one of the biggest challenges and one of the...
read DetailsBiologic
Cold Chain Services Across
Your Product Development Lifecycle
As your controlled-temperature therapy advances through its development lifecycle, planning and optimizing the pharmaceutical cold chain is key to keeping moving towards approval. Modality Solutions has the regulatory experience and engineering expertise to support your therapy from early phase to post-commercial—with integrated cold chain solutions for every phase.
Request a Consultation
Our Cold Chain Solutions
Our Cold Chain Services Across Clinical Phases
SERVICE TYPES BY PHASE |
|||
|
EARLY PHASE CLINICAL (PHASE I / II) |
LATE PHASE CLINICAL (PHASE II / III) |
FILING AND APPROVAL (READY TO FILE) |
COMMERCIAL |
|
Risk Assessment |
Transport Validation Master Planning |
Secondary Packaging Qualification |
Performance Qualification Reports |
|
Primary Packaging Qualification |
Drug Product Simulation Testing |
3PL Quality Agreements |
Cold Chain Optimization |
|
Logistics Network Design |
Thermal Packaging Qualification |
Performance Qualification Protocols |
|
|
Third-Party Logistics (3PL) Selection |
3PL GDP Audit |
Regulatory Filing Submission Support |
|
|
Formulation Optimization |
|||
|
Regulatory Support |
|||
|
Information Request Assistance |
|||
It’s Never Too Soon to Plan Your Cold Chain Strategy
Planning for your therapy’s cold chain early and working with an experienced cold chain engineering partner helps you avoid costly delays in getting your drug product to market. Biopharmaceutical manufacturers often get a late start on addressing their cold chain requirements. Or they assume their in-house resources will be sufficient—only to find they don’t have deep regulatory and engineering expertise specific to their novel, first-of-its kind therapy
Preparing for your cold chain validation early in the clinical development process and working with the experts at Modality Solutions can keep both your development work and your regulatory filing on track. Our team brings the unmatched cold chain regulatory and engineering expertise it takes to bring new therapies to market. We’ve worked with 125+ biologics, advanced therapies, and drug-device combination products—including the industry’s most innovative advanced therapeutics—and engaged in hundreds of successful regulatory interactions.
When is the right time to engage Modality Solutions?
- If we start in late Phase 2, we can develop robust data to predict your drug formulation’s stability throughout the cold chain, using advanced transport simulation testing.
- If we start in Phase 3, we can work quickly to meet tight filing deadlines, while recognizing the potential for regulatory submission delays or limitations in the degree of transport simulation testing we can provide.
Expert Cold Chain and Filing Support for Every Timeline
Whether your therapeutic is on an expedited approval pathway or a traditional approval timeline, we can provide a cold chain solution designed to get your drug product across the finish line successfully.
Discuss your Cold Chain needs
with a Modality Solutions expert
Talk to Us 
Related Insights
View All Resources
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 DetailsCold Chain Engineering
A Cold Chain Process Validation Guide: Part 2: Integrating your Cold Chain Management Systems
Biopharma supply chain excellence starts by integrating your cold chain. By integrating your cold...
read DetailsBiologic
