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Experience Counts

Regulatory Affairs & Quality Consultant

Trisha Skinner, Principal Consultant

Why choose QualiStrategix, LLC?

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. 

  • Regulatory Compliance

  • Strategic Planning & Excellence

  • Change Management

  • Operational Excellence

  • Quality Management Frameworks

  • Quality Control Solutions

  • Lean Six-Sigma Principles

  • Quality Engineering / Auditing

Our Approach

At QualiStrategix, we partner with clients as an integrated extension of their team, not just as consultants. Our approach is grounded in clarity, precision, and purpose. We meet each client where they are, tailoring our engagement to their stage of development, regulatory path, and operational maturity.

Every project begins with understanding: we take time to learn the science, the systems, and the people behind it. From there, we build actionable strategies that balance regulatory rigor with practical execution. Ensuring every deliverable moves your program forward, not just checks a box.

At the core of our work is a belief that regulatory and quality excellence should enable innovation, not hinder it. That’s why every engagement is designed to empower teams; building confidence, competence, and continuity long after our work is done.

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.

 

Get a Free Consultation Today!

Let's connect to discuss how we can work together to accomplish your needs. 
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