A well-designed Quality Management System (QMS) is more than a regulatory requirement. It serves as the backbone of a compliant organization and the enabler of reliable, high-quality clinical research. A fit-for-purpose QMS ensures that studies are conducted with consistency, integrity, and full alignment with ICH-GCP, FDA, EMA, and other global regulatory expectations.
Regardless of whether you are a biotech startup, a contract manufacturer, or a life science service provider, you need to implement a robust, phase-appropriate QMS to comply with the applicable regulations throughout the product life cycle.
I help organizations build realistic, sustainable quality systems applicable to the phase of their clinical program lifecycle, post-marketing world, as well as for service providers who support the life sciences.
• GxP-compliant SOP frameworks and governance
• Training, qualification, and documentation control
• Risk-based quality oversight and CAPA management
• Inspection readiness and regulatory alignment
• Independent QMS audits and gap assessments
