Comprehensive Quality Assurance & Compliance Services
Our Quality Assurance team provides end-to-end quality management solutions to ensure compliance with GCP, GLP, GMP, and regulatory requirements. We help maintain the highest quality standards throughout your clinical trials and product lifecycle.
Our experienced QA professionals implement robust quality systems that prevent deviations, ensure data integrity, and maintain regulatory compliance across all study phases.
We specialize in developing and implementing quality management systems, conducting internal and external audits, providing regulatory inspection support, and managing quality events. Our comprehensive approach includes risk-based quality management, CAPA implementation, vendor qualification, and continuous quality improvement initiatives. We ensure your clinical trials meet the highest standards of quality and regulatory compliance.
Frequently Asked Questions
Q: What regulatory standards do your QA services cover?
A: Our QA services cover all major regulatory standards including FDA 21 CFR Part 11, 50, 54, 56, 312, 314; EMA GCP guidelines; ICH E6(R2) GCP; ISO 9001:2015; ISO 27001; GDPR; and other international regulatory requirements. We provide comprehensive compliance solutions tailored to your specific needs.
Q: How do you approach risk-based quality management?
A: We implement a proactive risk-based quality management system that identifies, assesses, and mitigates risks throughout the clinical trial lifecycle. Our approach includes risk assessment methodologies, risk control planning, continuous monitoring, and metrics-driven quality oversight to ensure patient safety and data integrity.
Q: Can you support regulatory inspections and audits?
A: Yes, we provide comprehensive inspection readiness services including mock FDA/EMA inspections, audit preparation, inspection management support, and post-inspection response assistance. Our team has extensive experience supporting regulatory inspections and ensuring successful outcomes.
Our Quality Assurance Services Include
- Quality Management System Development
- GCP/GLP/GMP Audits & Assessments
- SOP Development & Management
- Regulatory Inspection Support
- Vendor Qualification & Oversight
- Risk-Based Quality Management
- CAPA Management & Tracking
- Training & Quality Culture Development
