Global Quality Services
We provide elevated experiences guided by our aim to deliver best-in-class Quality Assurance, ensuring compliance and supporting clinical trials leading to market approvals so that together, we can improve lives through transformative clinical research.
Navigate global regulations and compliance requirements
Our Quality Assurance team has the right knowledge and in-depth expertise to ensure effective quality oversight and help you navigate global regulations and compliance requirements.
Everything we do aims to meet and exceed customer and regulatory expectations. Our ownership mentality means carefully understanding the implications of every decision we make and acting in the best interests of the trial and participants, including consideration and compliance to the governing standards and regulations that apply.
Ingrained in our operations is the agility and technological capability to meet regulatory standards and navigate through changing demands of studies while ensuring the compliance, data integrity and safety of your trial. We always work to ICH and GCP standards and applicable regulatory requirements and guidance in the regions where we deliver services, ensuring compliance with local regulations, by leveraging local expertise and taking a risk-based approach.
Robust, harmonized Quality Management System
All our team members are trained on quality and regulatory compliance and global standard operating procedures that also anticipate and comply with regional or local regulatory requirements and our robust, harmonized Quality Management System (QMS) means we can assure you that everyone on your project team has been trained to meet the same high standards, wherever those services are delivered globally.
Our deeply experienced, global QA team, have extensive experience in strategically preparing for, hosting, managing and closing out regulatory inspections for our clients, supporting dozens of client audits annually with minimal to no findings including inspections from various regulatory bodies where we work, such as MHRA, FDA, AIFA, TFDA among others.
At Caidya, the Quality function is represented in our executive leadership team and we implement a number of organizational initiatives to maintain compliance and constantly explore ways to improve processes and standards, exploring the root causes of any quality issues and ensuring robust corrective and preventative actions are identified and implemented.
Robust Quality Assurance
- Full audit program of internal and external audits
- Deeply experienced global QA team in preparing, hosting and close out of inspections across MHRA, FDA, and other regulatory bodies
- Regular Executive leadership review and feedback on the QMS effectiveness, Quality Metrics, including internal and external audit feedback, awareness of changes to regulatory requirements affecting service delivery
- Performance of periodic external Quality certification audits of the QMS and compliance
- Supplier qualification, requalification auditing and maintenance of a qualified Master Vendor List of all GxP relevant vendors with vendor oversight
- Systematic approach to ensuring Inspection and Audit-readiness, through staff training and experienced, strategic QA planning and audit management, from preparation, conduct and audit close out.
- Development, maintenance of robust, industry leading global, Quality Management system, standards, SOPs, staff training and metrics
- Regulatory authority inspection support
- Gxp system risk assessment, validation, change control/management and periodic review
- Documentation review and change control
- GxP investigations/deviation reports/Quality Event/CAPA system
- Training
Personalized clinical research services
Across every stage of your clinical journey, we’re by your side to help you advance through clinical trials to get your therapy to patients and help bring your science to life.
Speak to one of our experts
Access the right people when and where you need them with personalized clinical services tailored to you and your trial.
The latest from Caidya
Explore our news and updates as we liberate the clinical research process.
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01/13/2025
Caidya Announces $165 Million Strategic Growth Investment from Rubicon Founders
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07/22/2024
Caidya Announces Leadership Transition: Barbara Lopez Kunz Named CEO
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06/12/2024