GxP Quality Assessment & Remediation

GxP Quality Management Systems (QMS) are essential for sponsors to uphold quality standards throughout the clinical development lifecycle. A robust QMS includes processes, technology, and roles to guide regulated activities. Inadequate systems can lead to compliance issues with GxP regulations, potentially resulting in FDA warning letters or rejection of clinical data.

For over two decades, our quality-focused consultants have crafted and implemented QMS systems for various life science companies.

Halloran's approach involves a comprehensive assessment to design a tailored, GxP-compliant QMS aligned with your organization's size, stage of development, and business model. Through this assessment, we:

• Identify non-compliance and process improvements
• Prioritize gaps with risk-based recommendations and an implementation plan
• Develop an integrated QMS linked to your strategic goals

The critical role of GxP QMS lies in ensuring product and process safety, efficacy, and quality within regulated sectors. We analyze your QMS components through document reviews and interviews, leveraging our industry knowledge to deliver a comprehensive implementation plan with specific recommendations for a future-state QMS.

We collaborate with your team to implement and lead quality-focused initiatives, leveraging cutting-edge technology platforms. Our partnership ensures compliance with GxP regulations and achievement of quality objectives linked to broader strategic goals.

Implementing and maintaining an effective GxP QMS is both a legal requirement and a strategic imperative for organizations in highly regulated sectors.