CrO Biosciences
CrO Biosciences, Inc., is a global, woman-owned, operated and controlled information management consulting firm located in Temecula, CA. They provide regulatory submissions, GCP inspection readiness, clinical trial support, and R&D Systems Exchange services to pharmaceutical, biotechnology, and medical device organizations. With over 60 years of combined experience, they focus on delivering high-quality, efficient, and effective services, staying ahead of industry trends, and fostering a personal touch with integrity and expertise.
Industries
Nr. of Employees
small (1-50)
CrO Biosciences
Temecula, California, United States, North America
Services
Consulting and execution for global regulatory strategy, preparation and submission of regulatory applications, electronic submission publishing and labeling support.
Turnkey managed regulatory operations providing publishing systems, archive and staffed support to act as an extension of client regulatory departments.
Governance, roadmap, configuration oversight, data migration, UAT/PQ validation, go-live planning and end-user support for enterprise R&D platforms.
Initial audits and mock-inspection services reviewing systems, processes, vendor oversight, trial activities and documentation to establish inspection readiness.
Operational publishing services including assembly, QC, finalization and delivery of submission-ready documents; support for publishing tool testing and process documentation.
Support for study design, study management, monitoring coordination, medical writing and clinical SOP development and optimization.
Consulting and execution for global regulatory strategy, preparation and submission of regulatory applications, electronic submission publishing and labeling support.
Turnkey managed regulatory operations providing publishing systems, archive and staffed support to act as an extension of client regulatory departments.
Governance, roadmap, configuration oversight, data migration, UAT/PQ validation, go-live planning and end-user support for enterprise R&D platforms.
Initial audits and mock-inspection services reviewing systems, processes, vendor oversight, trial activities and documentation to establish inspection readiness.
Operational publishing services including assembly, QC, finalization and delivery of submission-ready documents; support for publishing tool testing and process documentation.
Support for study design, study management, monitoring coordination, medical writing and clinical SOP development and optimization.
Expertise Areas
- Regulatory affairs and electronic submissions
- Clinical trial document management and TMF governance
- R&D systems implementation and governance
- GCP inspection readiness and auditing
Key Technologies
- eCTD and other electronic submission formats
- Electronic TMF platforms
- Cloud-based regulatory content management platforms
- GxP computer system validation methodologies
News & Updates
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Together, we’re collaborating to develop a series of service solutions to help you get ready and stay current with Veeva Vault solutions.
Together, we’re collaborating to develop a series of service solutions to help you get ready and stay current with Veeva Vault solutions.
Together, we’re collaborating to develop a series of service solutions to help you get ready and stay current with Veeva Vault solutions.
Access to this content has been restricted. Contact your internet service provider for help.
Together, we’re collaborating to develop a series of service solutions to help you get ready and stay current with Veeva Vault solutions.
Together, we’re collaborating to develop a series of service solutions to help you get ready and stay current with Veeva Vault solutions.
Together, we’re collaborating to develop a series of service solutions to help you get ready and stay current with Veeva Vault solutions.