Quality Management
Rely on our comprehensive Quality Management Systems services at Leorah Clinical, where we integrate ISO-compliant quality practices into all our work, consistently aim for regulatory compliance and continuous improvement, prepare for regulatory inspections, conduct in-depth analysis and audits, and provide expert consultation – learn more about how we can customize these services for you through our complimentary consultation.
Our Quality Management Systems services include but are not limited to:
- Robust Quality Management Systems: Our well-established systems, based on ISO 9001, ICH GCP, ISO 14155, ISO 13485, ISO 14971, NHMRC, and more, ensure quality is integrated into every aspect of our work at Leorah Clinical.
- Compliance and Continuous Improvement: We continually strive for compliance with applicable regulations and seek to improve our performance by maintaining high-quality study practices.
- Regulatory Inspection Preparedness: Our industry-experienced team puts in place thorough plans to proactively address regulatory inspections and challenging issues, mitigating potential risks before they arise.
- Quality Management System Analysis: Conducting GAP analysis to assess and enhance quality management systems, identifying areas for improvement and implementing effective strategies.
- Audits and Assessments: Offering a range of audits, including clinical site audits, pre-inspection audits, independent audits (vendor, database, and investigator sites), process and system audits, and regulatory document audits to ensure adherence to regulatory standards and best practices. Additionally, providing consultation on risk management and conducting risk assessments for submissions, as well as assisting sites in preparing for regulatory inspections.
Take advantage of our free consultation to learn more about our customized services.