For today’s advanced therapies, getting across the regulatory finish line and optimizing the commercial cold chain demands expertise in Cold Chain EngineeringTM, regulations, and testing. That’s what Modality Solutions provides.
We’re experts in optimizing the biopharmaceutical cold chain for novel, fragile, and controlled-temperature therapies and meeting the rigorous filing requirements for these advanced drug products. With an unmatched track record of regulatory filing success, the only contract transport simulation lab of its kind, and deep cold chain expertise, Modality Solutions is the trusted Сold Сhain EngineeringTM partner for leading pharmaceutical and biopharmaceutical companies.
Biopharmaceutical Innovators
For novel therapeutics on an accelerated approval pathway, the pharmaceutical supply chain has to be ready for the rigors of FDA review and the commercial market. Modality Solutions leverages our unrivaled cold chain expertise, in-depth regulatory knowledge, and proprietary transport simulation testing to help biopharmaceutical companies obtain fast approval for innovative drug products.
Cell and Gene
Therapy Developers
A complex, closed-loop supply chain and stringent regulatory requirements make the filing process especially demanding for cell and gene therapeutics. Modality Solutions applies deep knowledge of cell and gene therapies, unmatched cold chain expertise, and proven success in navigating a complicated regulatory landscape to get these novel drug products successfully reviewed and approved.
Drug-Device Combination Products
Medical technologies like drug-device combination products pose unique supply chain and regulatory challenges, including the need to bridge existing data for each component. Modality Solutions has the engineering know-how and regulatory experience to meet those challenges, with transport simulation testing and regulatory consulting services that ensure a successful drug-device filing.
Public Health CROs
To get vaccines and other therapeutics tested and deployed in developing countries with limited infrastructure, it takes a validated, optimized cold chain. Modality Solutions works with CROs, government agencies, industry sponsors, and other NGOs to assess, validate, and optimize the cold chain in these high-risk environments, making vital therapies accessible to vulnerable patient populations.
Service Providers
When your consulting client or portfolio business works with fragile or controlled-temperature therapeutics, you need assurance that the cold chain can stand up to regulatory scrutiny and the commercial environment. Regulatory consultants tap Modality Solutions to supplement their work with our cold chain engineering expertise and transport simulation testing, and biopharmaceutical investors strengthen their due diligence of portfolio businesses with our cold chain validation services.
For innovative, fragile, and temperature-controlled therapies, Modality Solutions is uniquely qualified to maximize your odds of a smooth filing and ensure your cold chain is optimized for the commercial market. We offer a wide range of engineering, testing, and consulting solutions that get your drug product set up for success.
Browse through our options based on your
therapy type or current clinical phase
Modality Solutions continues to move innovative therapeutics forward, drawing on our in-depth cold chain expertise, regulatory experience, and transport simulation testing capabilities. Our track record of success across a wide range of therapies is unmatched in the industry.
125+
drug and drug-device
combination products
300+
thermal packaging
qualifications
250+
Successful Regulatory
Interactions
75+
drug approvals
in last three years
8
cold chain
regulatory guidance
documents authored
Discover why leading pharma biopharma companies choose Modality Solutions
Modality Solutions combines the technical capabilities and engineering know-how to support your fragile or controlled-temperature therapeutics at every step—from filing preparation, through the filing and approval process, to commercialization.
Cold Chain Engineering
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Transport Simulation Lab
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AI-Driven Cold Chain Optimization
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Emergency Response to Regulatory Inquiries
Learn More“We are very delighted to inform you the FDA has approved tafasitamab. On behalf of the whole team, we want to thank you for your great support. Well done!”
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