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.

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Cold Chain Services Across <br>Your Product Development Lifecycle

SERVICE TYPES BY PHASE
EARLY PHASE CLINICAL (PHASE I / II)	LATE PHASE CLINICAL (PHASE II / III)	FILING AND APPROVAL (READY TO FILE)	COMMERCIAL (POST-APPROVAL)
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
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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.

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.