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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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
(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

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.

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with a Modality Solutions expert

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