The QualityHub Difference
Founded on the principles of quality and the commitment to continuous improvement, QualityHub has become known as a top FDA compliance consultant, proven leader, mentor and guiding light for the medical device and pharmaceutical industries.
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.
Furthermore, we 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 enabling organizations to grow, build and innovate.
QualityHub works with companies large and small all over the world in order to help them succeed. Our reputation as a top FDA compliance consultant 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 or consent decrees.
We provide consulting support in several technical areas, but not limited to:
- Product Development - including design controls and risk management
- Complaint Handling and Reporting
- Production & Process Controls – including process validation and computer software validation
- Supplier Controls
- Internal Auditing
- Management Controls
- Document Control
- Drug GMP
- Clinical Compliance
- And More!
For nearly 20 years we have been providing trusted advice and solutions to the medical device and pharmaceutical industries. We do this by tackling the needs of today and tomorrow and turning strategy into action to spark positive change. Thus, helping clients achieve extraordinary results, innovate cutting edge products and define the future.
We work with ambitious clients who want to shape the future, not avoid it. Our dedication to our clients shows in everything we do. We partner with our clients as one team with a shared motivation to achieve incredible outcomes that define the way they do business. This mutual trust is why QualityHub continues to outperform the competition while making a difference in the lives of those we serve—delivering better, faster, and more enduring results.
Our approach to quality can be summarized in one phrase: "ensuring customer success". This is our competitive advantage.
We hear over and over again that it feels different to work with QualityHub. Why? It’s because our consulting firm is designed to function as one cohesive team unified by a strong set of core values, mission and customer success.
We take a consistent approach to recruiting the right experience and expertise so we can quickly deliver the right team. We bring experts in every relevant discipline to each client’s challenge and the value they deliver goes deeper than their resumes. Our consultants include engineers, scientists, medical doctors, nurses, business leaders, 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 right 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.
This dynamic, entrepreneurial culture makes QualityHub’s teams extraordinarily effective to every client, anywhere in the world. We have helped many of the world’s leading companies unlock their potential by navigating and delivering in both today’s real-world and tomorrow’s unknown future. Let us help you bring your goals to life.
Integrity First | Quality-Impassioned | Mission-Driven | Educate & Inspire | Communicate Fearlessly
Our Core Values
How We Fit Into Your Compliance Story
Doing the Right Thing
What sets us apart as a company is our passion for doing the right thing. QualityHub brings together like-minded professionals who believe quality and compliance are more than a set of procedures and policies. Quality and compliance involve core values and devotion. It’s a religion of sorts, that must be practiced day in and day out. It’s driven by passion and realized through our commitment to serving.
With our help, the drug and device industry will provide safe and effective products to patients worldwide, in a manner that ensures compliance with governing requirements while adhering to the highest quality principles.
To be your trusted partner for customized end-to-end quality and compliance solutions.
Our Quality Policy
QualityHub will provide professional services to our clients in order to assist them in continually improving their business, products and state of compliance. As a trusted quality resource, we strive to continually improve our services and product offerings.
Upholding Compliance Here and Abroad
An International Reach
Since 2007, QualityHub has equipped our consultants with the tools and education they need to excel in the US and abroad. Whether it’s in the heart of Mexico or in the UK, QualityHub meets its clients’ needs wherever they are. Our consultants are not only respectful of the cultures they’ll be encountering but are often conversational in the language of the country they’ll visit.
Due to our expansive international experience, our consultants are well-versed in a variety of compliance requirements and regulations, including EU MDR and MDSAP.
Our Commitment to the Community
We believe mentoring, giving and generosity are essential components for any successful business. In addition to supporting our local community, QualityHub is involved with two charitable foundations.
The Wells Charitable Foundation, Inc. was established in 2014, by the QualityHub founders, Timothy & Cherie Wells. Tim and Cherie have always felt it is important to give back. For the last 40 years, they have been providing gifts and grants locally, nationally and internationally. The primary contributor to the Foundation is QualityHub, Inc., which provides a portion of its profits to the foundation on an annual basis.