Modality Solutions has been a leader in biopharmaceutical cold chain engineering for over a decade, with a team of experts in regulatory affairs and life sciences. Our deep expertise in packaging design, shipment lane validation, drug product simulation testing, and stability studies allows us to provide clients with a comprehensive regulatory approach, ensuring compliance with the latest global regulations.
With a focus on global regulatory requirements, our team helps clients navigate complex regulations, seeking out commonalities and optimizing the validation process. We are dedicated to delivering the last mile of the supply chain, providing the continuity and control necessary to ensure successful product delivery to the patient.
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Specialized Global Regulatory Expertise
Modality Solutions’ global expertise is rooted in a clear understanding of the patchworked global regulatory requirements across multiple agencies and jurisdictions. The team works with clients and pharma manufacturers to develop validation reports that meet the global regulatory requirements for the appropriate locations.
The Negatives of Real-World Shipping Studies for the Biopharma Cold Chain
There’s a time and a place for Real-World Shipping studies, but when it comes to testing drug product robustness at the operating edge of your supply chain against concurrent transportation hazards, real-world shipping studies just won’t cut it.
Andrew Larrigan outlines key reasons why real-world shipping studies are inadequate, and details the clear solution below.