We support clinical trials of all sizes, both domestic and international, through comprehensive clinical supply services and a global network.
The nine locations in the United States, Europe, and the Asia-Pacific region are clinical trial drug packaging sites compliant with cGMP, and the more than 50 depots across six continents are audited clinical trial drug supply facilities. Leveraging this high-level global network and extensive expertise in global supply chains and clinical trial drug supply management, we provide flexible and integrated services that cater to Phase I through Phase IV clinical trials. As clinical trials become increasingly complex and individually designed, there is a pressing need to bring newly developed pharmaceuticals to market more quickly. However, the new drug development process frequently encounters new challenges, necessitating prompt and accurate responses each time. To address this, Catalent offers tailored solutions required for clinical trials. By flexibly responding to various challenges at every step of the clinical trial process—such as direct procurement of comparator drugs, comprehensive clinical trial drug packaging, labeling, storage in appropriate environments, global distribution, and innovative supply models—we accelerate the speed of bringing new pharmaceuticals to market. With these diverse services and capabilities, along with proven track records in various countries, we support domestic, international, and global clinical trials as a comprehensive clinical trial drug supply partner.
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basic information
■Project and supply management in clinical trials ■Global procurement of comparator drugs ■Manufacturing of investigational drugs and blinding (over-encapsulation and masking) ■Primary packaging ■Secondary packaging and labeling of investigational drugs ■Global distribution and logistics management systems ■Cold chain ■Recovery, investigation/verification, and disposal of investigational drugs
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Applications/Examples of results
■Lifecycle management of the global supply chain from manufacturing to final manufacturing responsibility and disposal ■Direct procurement of comparator drugs from new drug manufacturers, major pharmaceutical wholesalers, and local distributors ■Automated over-encapsulation ■Automated high-speed blister packaging and bottle filling lines ■Automated wallet packaging ■Room temperature, CRT (15-25°C), refrigerated (2-8°C), frozen (-15 to -25°C), ultra-low temperature freezing (-40°C to -60°C, -70°C to -90°C, cryogenic) ■Disposal and disposal certification in accordance with local regulations
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Company information
Our company is a global enterprise that provides advanced and excellent development and manufacturing technologies in the fields of oral pharmaceuticals, biopharmaceuticals, and consumer health. As an innovator in formulation development and manufacturing, we propose better treatment and health-appropriate solutions, and we support the stable delivery of high-quality products that are highly reliable.