Cornerstone Quality Consulting: Building Foundations of Excellence

We have over 16 years of experience in quality assurance, helping organizations ensure regulatory compliance and meet global regulatory standards in the development of pharmaceutical products. We specialize in providing quality and compliance consulting services, focusing on areas such as training, global inspection management, inspection readiness and auditing, quality assurance resourcing, clinical monitoring, project management, and procedure development. Our team serves as a quality and compliance resource, supporting sponsors in clinical trial and research regulatory compliance activities.

With a commitment to delivering excellence and maintaining integrity, our mission is to support our clients in achieving their quality and compliance goals, ensuring successful outcomes for both patients and organizations in the development of pharmaceutical products.

Our key areas of expertise include:

• GxP compliance and auditing for clinical sites, vendors/suppliers, and clinical and non-clinical laboratories
• Quality assessments of research laboratories
• Computer system validation compliance
• GCP training for sponsors and clinical site staff
• Global inspection readiness training and on-site inspection support
• Mock inspections
• Risk management, including deviation investigations, root cause analysis, and CAPA implementation
• Clinical monitoring
• Quality management systems (QMS) design and implementation
• Procedure development