Modality Solutions


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Biopharma Cold Chain Engineering with State-of-the-Art Transport Simulation Laboratory

Modality Solutions specialises in the implementation of cold chain management systems for the pharmaceutical industry.


Modality Solutions is the leading expert in cold chain engineering. We specialise in optimising the biopharmaceutical cold chain for novel, fragile, and controlled-temperature therapies and meeting the rigorous filing requirements for these advanced drug products.

Focusing on the biopharmaceutical, food and life sciences industries, we are deeply committed to safeguarding the integrity and quality of temperature-sensitive products throughout their entire supply chain journey. At Modality Solutions, our unwavering focus is on addressing the unique challenges and requirements intrinsic to these industries, showcasing diverse services and competencies.

Our primary objective at Modality Solutions is to optimise pharmaceutical and biotechnological cold chains, emphasising expediting the regulatory approval process. Our unparalleled success in obtaining approvals within the biopharmaceutical realm is a testament to our distinctive transport simulation lab, multi-disciplinary engineering expertise, and collaborative approach. These factors collectively position us as the preferred partner for addressing the specific cold chain engineering needs of biopharmaceuticals.

The only multi-modal contract lab with the capability to test for all five transportation hazards, concurrently and at the edge of your cold chain’s operating space.
We understand the complexities of transporting finished drug products and raw materials with cold chain requirements—and we offer a complete, robust methodology that consistently meets regulatory requirements.
No matter how complex your cold chain challenge, Modality Solutions can craft a customised engineering solution that meets it head-on, bringing your therapy through a successful filing.
Through performance qualification studies, Modality Solutions ensures the integrity of temperature-sensitive products by verifying their stability throughout the supply chain.
With a commitment to both product protection and environmental responsibility, we deliver innovative packaging solutions that align with industry standards and promote sustainable practices.
With unrivalled cold chain expertise and technical writing experience, Modality Solutions is uniquely qualified to help you respond to emergency requests in a way that maximises the odds of a fast, successful filing.

Contract Transport Simulation

With advanced therapies, where regulatory compliance is paramount, Modality Solutions excels in guiding products through the regulatory approval process while optimising commercial cold chains. Our expertise in cold chain engineering, coupled with strict adherence to regulations and comprehensive testing, is crucial for ensuring the success of advanced therapies in the market.

We have a distinguished track record of success in regulatory filings that is complemented by the only contract transport simulation lab of its kind, which showcases our unwavering commitment to innovation and excellence in the field.

Our collaborative and client-centric approach is evident in our role as the trusted cold chain engineering partner for leading pharmaceutical and biopharmaceutical companies. Our expertise extends beyond addressing current industry challenges to anticipating and preparing for the evolving landscape of temperature-sensitive product management. Our proven track record, cutting-edge facilities, and a team of seasoned professionals uniquely position Modality Solutions as an industry leader.

Regulatory Support

Recognising the evolving landscape of the pharmaceutical and biopharmaceutical sectors, particularly in the context of advanced therapies, we have honed our expertise to meet intricate challenges related to sensitivity to temperature variations and the need for controlled environments. This commitment ensures that advanced drug products can successfully navigate the complex regulatory landscape.

Our commitment to excellence is demonstrated through our emphasis on cold chain engineering, which goes beyond conventional cold chain management practices. It encompasses a holistic and specialised approach tailored to the unique requirements of biopharmaceuticals. We are well aware that success in this field requires a comprehensive understanding of regulatory frameworks, testing protocols, and the ability to adapt to emerging trends.

In summary, Modality Solutions is a beacon of innovation and excellence in cold chain engineering. Our holistic and collaborative approach, coupled with a proven track record, positions us as the go-to partner for pharmaceutical and biopharmaceutical companies seeking to optimise their cold chains. As the industry continues to evolve, Modality Solutions remains at the forefront, ready to meet emerging challenges and contribute to the success of temperature-sensitive products in the global market. Our dedication to excellence and anticipation of industry trends ensure our continued leadership in the dynamic field of cold chain engineering.

Cold Chain Consulting

Modality Solutions specialises in engineering consulting, offering expertise in designing, implementing and optimising cold chain processes to maintain products within specified temperature ranges. We conduct thorough risk assessments, identify vulnerabilities, and develop strategies to mitigate risks during storage, transportation, and distribution. Additionally, Modality Solutions is committed to assisting clients in navigating complex regulatory requirements ensuring strict adherence to industry standards and guidelines.

With a focus on the biopharmaceutical, food, and life sciences industries, we provide tailored solutions to meet the unique needs of our clients. Through our comprehensive services, Modality Solutions ensures the integrity and quality of temperature-sensitive products throughout their supply chain journey.

Transport Validation

Modality Solutions excels in protocol development, crafting customised validation protocols and testing procedures to affirm the effectiveness of cold chain processes. Through performance qualification studies, Modality Solutions ensures the integrity of temperature-sensitive products by verifying their stability throughout the supply chain.

Leveraging advanced data analysis, Modality Solutions offers valuable insights into temperature excursions and deviations, empowering clients to make informed decisions regarding their products. This meticulous approach to data analysis enhances the overall understanding of cold chain processes and aids in optimising performance.

With a commitment to precision and excellence, Modality Solutions plays a crucial role in safeguarding the quality and reliability of temperature-sensitive products for its clients in diverse industries.

Packaging Solutions

Modality Solutions specialises in package design, creating and testing temperature-controlled packaging solutions to shield products from temperature fluctuations, shock, and environmental stresses. Through rigorous thermal testing, Modality Solutions ensures that these packaging solutions maintain the required temperature profiles under diverse conditions.

Emphasising sustainability, we actively pursue eco-friendly packaging options to reduce waste and lessen environmental impact. With a commitment to both product protection and environmental responsibility, we deliver innovative packaging solutions that align with industry standards and promote sustainable practices.

Regulatory Expertise

Navigating the maze of regulatory requirements is daunting for many companies, and our team of experts possesses an unparalleled understanding of the regulatory complexities surrounding cold chain management. We ensure our clients comply with these stringent requirements, significantly reducing the risk of regulatory violations and associated penalties. Our commitment extends not only to safeguarding our clients’ reputations but also to ensuring the safety and efficacy of their products.

White Papers

  • Case Study: Immunomedics

    Immunomedics ( is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer.

  • A Cold Chain Process Validation Guide

    Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets - these are some of the challenges facing cold chain management professionals every day. Solutions that deliver value in the supply chain and enhance your regulatory reputation are required every day, around the globe.

  • The Challenges of Cold Chain Validation for Regenerative Medicine

    Regenerative medicine is a novel biomolecular approach to exciting new clinical therapies. Generally, this grouping involves three major therapy applications: cell therapies or stem cell injections; immunotherapy, regeneration by biologically active molecules administered alone or as secretions by infused cells; and tissue engineering, transplantation of laboratory-grown organs and tissues.

  • Case Study: Bristol-Myers Squibb

    Bristol-Myers Squibb (BMS) is a global biopharmaceutical company headquartered in New York City that specialises in discovering, developing and delivering innovative medicines for patients with serious diseases.


Press Releases

Products & services

  • Transport Simulation Laboratory

    Modality Solutions operates our Advantage Transport Simulation Laboratory™ that has been continuously validated to current GMP (Good Manufacturing Practices) since its installation in 2012.

  • Thermal Package Design and Qualification

    The need for a standardized package qualification process was recognized by the International Safe Transit Association (ISTA) in April 2014. Modality Solutions partnered with ISTA and spearheaded this standardization process.

  • Clinical Trial Operations

    Modality Solutions is the leader in clinical trial operations for vaccines for infectious diseases in emerging markets because we understand the challenges healthcare staff experience with proper storage and handling risks associated with temperature-controlled vaccines and biologics.