Precision-Tuned Services to Simplify your Challenges
Qualistrategix empowers life sciences companies to build audit-ready quality systems and navigate global regulations with confidence, offering expert support in QMS design, FDA/EMA submissions, and international registrations. Leveraging Lean Six Sigma and strategic leadership, we transform complex science into clear, compliant documentation while driving efficiency and cross-functional success
Navigate global regulatory complexity with confidence.
Translate science and compliance into clear, usable documentation.
Build & maintain audit-ready quality systems.
Drive performance, efficiency, and regulatory alignment.
What We Offer
About QualiStrategix, LLC
Our Mission
At QualiStrategix, our mission is to empower life science innovators to bring safe, effective, and compliant products to market through strategic, science-driven solutions.
We bridge the gap between regulatory expectations and practical execution, delivering clarity, structure, and confidence at every stage of development.
Our goal is to elevate quality and regulatory strategy from a compliance requirement to a true competitive advantage.
Experience Matters
With over 10+ years experience in quality engineering across highly regulated sectors, Trisha Skinner has consistently focused on ensuring compliance, optimizing processes, and safeguarding product integrity in life-critical environments.
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Regulatory Compliance
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Strategic Planning & Excellence
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Change Management
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Operational Excellence
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Quality Management Frameworks
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Quality Control Solutions
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Lean Six-Sigma Principles
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Quality Engineering / Auditing