キャタレント・ジャパン List of Products and Services

The ideal model for remote clinical trials such as DtP and StP is to be flexible and accurately address the needs of patients and the protocol. With Catalent's "FlexDirect" Direct-to-Patient service, sponsors can make strategic choices flexibly. In addition to consistent supply support from Catalent, including traditional site shipments, site-to-patient shipments (StP), and direct-to-patient shipments (DtP), customized support for specific needs (such as emergency shipments) is also possible. Patient needs vary each time depending on the situation. This "FlexDirect" Direct-to-Patient service model allows for flexible responses to any situation. More detailed information is also available here: clinical.catalent.com/solutions/flexdirect-direct-to-patient-services/

• others

Clinical trials are becoming globalized and complex, with expensive drugs and control medications being used, making supply management in clinical trials a very important issue. A clinical trial strategy that optimizes costs and minimizes waste contributes to ensuring an adequate supply throughout the trial period. Features: • Required quantities of investigational drugs, control medications, etc. • Inventory levels and reserve stock at appropriate sites • Balance of supply quantities and shipping frequency to manage the budget For more detailed information, please download the catalog.

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Our sourcing specialist team leverages a global network of major manufacturers and key wholesalers to efficiently procure a variety of pharmaceuticals, even for items that are difficult to source, in the quantities you require. CatTalent delivers comparator drugs promptly to any location around the world through its global storage and distribution network for clinical trial drugs. Whether you only need procurement of comparator drugs or require comprehensive services such as over-encapsulation, blinding, packaging and labeling, storage and distribution, or regulatory consulting, we can customize procurement-related services to meet your needs.

• Contract manufacturing

We would like to introduce the clinical trial-related services provided by Catalent Japan, Inc. We have established a comprehensive clinical trial-related service hub in Japan. We store investigational drugs according to the needs of clinical trials and trial sites both in Japan and overseas, and we deliver the investigational drugs to the necessary locations when patients need them. We offer investigational drug supply solutions tailored to customer requests and provide multilingual support in Japanese, English, Chinese, and Korean. 【Services】 ■ Creation of labels and cartons for clinical trials ■ Primary and secondary packaging (bottles, blister packaging, kit assembly, etc.) ■ Storage and delivery of clinical trial materials (15–25°C, 2–8°C, -20–-80°C) ■ Import and export support (international transportation arrangements and customs assistance) ■ Collection/disposal management suitable for the Japanese market ■ Procurement of comparator drugs from domestic and overseas sources ■ Qualified Person services (EU) ■ IOR import agency services (for overseas) ■ Over-encapsulation (for overseas sites) ■ Randomization and allocation ■ Clinical supply management (support for investigational supply management) *For more details, please refer to the PDF document or feel free to contact us.

• Contract manufacturing
• Processing Contract

The company name of Catalyst Japan Inc. is a combination of Catalyst + Talent. We respond to needs at every stage, from development services for pharmaceuticals and biologics to delivery technologies and supply solutions. With over 75 years of history, we possess extensive expertise, a wide range of services, and innovative technologies that contribute to rapid market entry, improved product performance, and reliable manufacturing and packaging. 【Business Description】 ○ Pharmaceutical Development and Manufacturing For more details, please contact us or download the catalog.

• Contract manufacturing
• Processing Contract

Our company has been globally expanding contract manufacturing of oral dosage forms, starting with soft capsules manufactured in Japan for over 40 years. From early-stage activities such as high-throughput screening of active pharmaceutical ingredients and the development of absorption-enhancing formulations, to the manufacturing of various clinical trial drugs and patches for applications and pharmacovigilance, we provide a range of services tailored to our customers' needs, including commercial production. Additionally, we offer services for contract development and manufacturing of sterile formulations and biologics (such as the development of production cell lines). [Examples of Development and Manufacturing] ■ Oral Dosage Forms and Inhalation Products - Soft capsules, tablets, powder-filled capsules, granules, Zydis orally disintegrating tablets, controlled-release formulations, inhalation products ■ Sterile Formulations - Injectable products (vials, pre-filled syringes, cartridges), blow-fill-seal (BFS) formulations ■ Biologics - Development of production cell lines (animal cells), process development, scale-up, cGMP manufacturing of biologics active pharmaceutical ingredients ■ Clinical Supply and Services *For more details, please refer to the PDF materials or feel free to contact us.

• Contract manufacturing
• Processing Contract

Catalent Japan, Inc. provides a variety of services essential for clinical trials in the development and manufacturing of new drugs. As a hub for clinical trial-related services, we have world-class facilities in the United States (Kansas City, Philadelphia) and have established a GMP-compliant facility in Kakegawa, Japan, following our locations in the United Kingdom, Germany, Singapore, and Shanghai. To meet the growing global demand, we are strengthening our network across the world. [Main Services] ■ Project Management and Clinical Supply Management ■ Storage and distribution under conditions suitable for the product ■ Handling of refrigerated and frozen items ■ Secondary packaging and labeling ■ Recall and disposal ■ Sourcing of comparator drugs, etc. ■ Manufacturing and branding of investigational drugs *For more details, please refer to the PDF materials or feel free to contact us.

• Contract manufacturing
• Processing Contract

Our company globally provides advanced drug delivery technologies, pharmaceuticals, biopharmaceuticals, healthcare products, and global clinical trial supply services. With experience in over 5,000 clinical trials, we achieve a 99% on-time delivery rate for more than 150,000 delivery needs conducted annually in 80 countries. We respond swiftly to needs not only for local trials in Japan but also for trials conducted in Japan as part of global studies. Additionally, we can provide services that cater to the detailed requests of the Japanese market. 【Services We Offer】 ■ Project management and clinical supply management ■ Storage and delivery under conditions tailored to the product ■ Handling of refrigerated and frozen items ■ Primary and secondary packaging and labeling ■ Retrieval and disposal ■ Sourcing of comparator drugs, etc. ■ Manufacturing and branding of investigational drugs *For more details, please refer to the PDF document or feel free to contact us.

• Contract manufacturing
• Processing Contract