About QualityHub
We Focus on Processes, People, and Results to Deliver the Extraordinary.
Doing the right thing and always providing the highest quality solutions is at the heart of our success. We do that by seeking out like-minded professionals who share that vision and have the expertise to make it happen. Nurturing, leading, and empowering our team ensures the success of the projects we work on and the success of our clients.
We also help clients create change that matters. We partner with our clients to transform their organizations in ways that matter most to them by attacking their most important challenges. With a deep commitment to excellence, we drive complex change that enables organizations to grow, build, and innovate.
Experts in Compliance
QualityHub works with companies large and small around the world to help them succeed. Our reputation as a top compliance consultancy comes from our comprehensive experience and track record. We have played major roles in establishing strategies to address quality system gaps communicated through FDA-483s, warning letters, consent decrees, and other enforcement actions.
We provide support in various technical areas, including:
- CAPA (Corrective and Preventive Action)
- Clinical Compliance
- Complaint Handling and Reporting
- Computer Software Validation
- Design Control
- Document Control
- Drug GMP
- Internal Auditing
- Management Control
- Process Validation
- Product Development
- Production and Process Controls
- Risk Management
- Supplier Controls
- Training
- And much more!
Measured by Client Success
For more than 20 years we’ve provided trusted advice and solutions to regulated industries including MedTech and pharma. We do this by tackling the needs of today and tomorrow and turning strategy into action to spark positive change. This assists companies in achieving extraordinary results, developing cutting-edge products, and defining the future.
We partner with ambitious clients who are determined to shape the future, not simply react to it. Our unwavering commitment is reflected in everything we do. By working side by side with our clients as one unified team, we share a common drive to achieve exceptional outcomes that redefine how they operate. This strong foundation of mutual trust is what allows QualityHub to consistently rise above the competition – delivering smarter, faster, and longer-lasting results that make a meaningful difference.
Ensuring customer success summarizes our approach to quality. This is our competitive advantage.
Defined by Our People
We repeatedly hear that it feels different working with QualityHub. Why? Because our consultancy is designed to function as one cohesive team unified by a strong set of core values, a clearly defined mission, and client success.
We take a consistent approach to recruiting the proper experience and expertise so we can quickly deliver the proper team. We bring experts in every relevant discipline to each client’s unique challenges, and the value they deliver runs deeper than their resumes. Our consultants include engineers and scientists; healthcare workers including doctors and nurses; business leaders and entrepreneurs; and policymakers. They join QualityHub for the opportunity to apply their talents to complex and critical challenges. Our people are the heart of our organization.
Our executive leadership team sets the agenda and goals for our consultants worldwide and is instrumental in laying the foundation for propelling our business forward. They help bring together the proper people and empower them to learn, grow and advance, which fosters a collaborative and supportive environment to make a long-term positive impact – consequently advancing QualityHub by helping others grow.
Our Executive Leadership Team defines the vision and strategic goals for our consultants around the globe, playing a key role in driving our business forward. They unite the right talent and empower individuals to learn, grow, and succeed – cultivating a collaborative and supportive culture that delivers lasting, positive impact. In doing so, they not only strengthen QualityHub but also help others thrive along the way.
QualityHub’s dynamic, entrepreneurial culture enables our teams to deliver exceptional value to clients across the globe. We’ve helped many of the world’s leading companies unlock their potential by thriving in today’s complex landscape while building for the challenges of tomorrow. Let us help you bring your vision to life.
Employee-Owned
In 2024, QualityHub transitioned to an Employee Stock Ownership Plan (ESOP), a business model that shifted and strengthened employee support. The ESOP has created a more rewarding work experience and allows our employees to share in the consultancy’s continued growth.
Our Core Values
Integrity First | Quality-Impassioned | Mission-Driven | Educate & Inspire | Communicate Fearlessly
Always Do the Right Thing.
What distinguishes QualityHub is our genuine passion for doing what’s right. We unite professionals who recognize that quality and compliance go beyond just procedures and policies – they are rooted in core values and unwavering dedication. These principles guide us every day, fueled by passion and fulfilled through our commitment to serving others.
An International Reach.
Since 2004, QualityHub has provided our consultants with the tools and training necessary to succeed both in the US and internationally. From the heart of Mexico to the UK, we consistently meet client needs wherever they may be. Our consultants show deep respect for the cultures they engage with and often communicate fluently in local languages to foster stronger connections.
Due to our expansive international experience, our consultants are well versed in a variety of compliance requirements, regulations, and programs, including the EU’s Medical Device Regulation (MDR) and the Medical Device Single Audit Program (MDSAP) from the International Medical Device Regulators Forum (IMDRF).
The Foundation.
We believe mentoring, giving, and generosity are essential components for any successful business. In addition to supporting our local community in Orlando, FL, QualityHub is intimately involved with The Wells Charitable Foundation.
QualityHub founders Tim & Cherie Wells established the foundation in 2014 because they strongly believe in the importance of giving back. The primary contributor to The Wells Charitable Foundation is QualityHub, which donates a portion of its annual profits.
