Chugai Pharma USA
Chugai Pharma USA, Inc. (CPUSA), located in Berkeley Heights, NJ, is a wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd. (Chugai). CPUSA supports the planning and execution of global and U.S. clinical programs for Chugai originated innovative new drug candidates. The company is committed to creating and delivering innovative products and services for the medical community and human health worldwide, with a focus on oncology and other therapeutic areas with unmet medical needs. It maintains a strategic alliance with Roche, which acquired a majority stake in Chugai, and supports global development and market access for Chugai's products.
Industries
Nr. of Employees
large (251-1000)
Chugai Pharma USA
Services
Clinical development support
Planning and operational execution support for global and U.S. clinical programs, including study management and coordination with global project teams.
Early clinical development services
Execution of first-in-human and proof-of-concept studies to assess safety and preliminary efficacy of novel candidates.
Regulatory affairs and submission support
Global regulatory strategy development, preparation of regulatory dossiers, and lifecycle management with a focus on first-time-right submissions to regulatory authorities.
Quality assurance and compliance services
Quality Management System implementation for regulated activities, GCP compliance, audit programs, issue management, document control and training.
Pharmacovigilance and safety monitoring services
Safety oversight and pharmacovigilance functions to support clinical programs and regulatory requirements.
Market research and business insight services
U.S. market research and strategic insight to inform development planning and commercialization strategy.
Clinical development support
Planning and operational execution support for global and U.S. clinical programs, including study management and coordination with global project teams.
Early clinical development services
Execution of first-in-human and proof-of-concept studies to assess safety and preliminary efficacy of novel candidates.
Regulatory affairs and submission support
Global regulatory strategy development, preparation of regulatory dossiers, and lifecycle management with a focus on first-time-right submissions to regulatory authorities.
Quality assurance and compliance services
Quality Management System implementation for regulated activities, GCP compliance, audit programs, issue management, document control and training.
Pharmacovigilance and safety monitoring services
Safety oversight and pharmacovigilance functions to support clinical programs and regulatory requirements.
Market research and business insight services
U.S. market research and strategic insight to inform development planning and commercialization strategy.
Expertise Areas
- Clinical trial management
- Early clinical development (Phase I / Proof-of-Concept)
- Regulatory strategy and submissions
- Quality assurance and GCP compliance
Key Technologies
- Clinical trial registries and portals
- Data analytics and algorithm development
- Biologics development platforms
- Clinical operations systems