GxP Quality Management System (QMS) Development

GxP Quality Management Systems (QMS) play a pivotal role in overseeing quality across all phases of the clinical development lifecycle. A robust QMS encompasses essential processes, technology, and roles, guiding an organization's activities in performing regulated tasks. Inadequate systems can hinder the efficient demonstration of compliance with GxP regulations for biotech or pharmaceutical products, potentially leading to FDA warning letters or non-acceptance of clinical data.

For over two decades, our quality-focused consultants have crafted and implemented numerous QMS systems across a spectrum of life science companies. Our comprehensive approach includes:

• QMS Assessment: Reviewing existing QMS elements
• Analysis & Report-Out: Identifying compliance gaps and risks
• Development: Crafting detailed, fit-for-purpose implementation plans
• Remediation: Assisting in quality document development and revision

Our assessments are tailored to your organization's size, development stage, and business model. By conducting a QMS assessment, we help:

• Identify non-compliance, pain points, and process improvements
• Prioritize gaps and provide risk-based recommendations with detailed implementation plans
• Partner with your teams to develop an integrated QMS aligned with strategic goals