Mobilizing the right balance of industry expertise and practical solutions to deliver unparalleled results.

Medical Devices

Pharmaceuticals

Combination Products

Biologics

Who We Are.

Trusted. Proven. Chosen.

With 20+ years of proven success and a roster of returning clients, QualityHub isn’t just experienced – we are experience, built on trust, results, and lasting relationships. We transform goals into outcomes and foster bonds that stand the test of time.

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On-Demand Talent
for the Lifecycle of
Your Regulated Product.

Talent Categories
Product Development/R&D Quality Assurance Regulatory Affairs Manufacturing & Operations Supply Chain Clinical Program/Project Management

Product Development/R&D

When projects pile up and timelines tighten, QualityHub delivers product development and R&D professionals who keep things moving. Our experts plug in fast, bring fresh perspectives, and drive progress without missing a beat.

> Find out how QualityHub has your staffing needs covered for product development and R&D.

Quality Assurance

Need sharp, reliable QA talent – right now? QualityHub connects you with experienced Quality Assurance experts who hit the ground running. From audit prep to process validation, our professionals keep your quality system compliant, efficient, and stress-free.

> Find out how QualityHub has your QA staffing needs covered.

Regulatory Affairs

Regulatory challenges move fast, so make sure your team moves faster. QualityHub matches your company with longtime Regulatory Affairs pros who seamlessly integrate, tackle complex requirements, and keep your projects on track.

> Find out how QualityHub has your RA staffing needs covered.

Manufacturing & Operations

Need skilled manufacturing and operations experts who are ready on Day One? QualityHub delivers top-tier talent fast so you never miss a beat. Whether it’s ramping up production or creatively handling unexpected demands, our experts keep things running smoothly.

> Find out how QualityHub has your staffing needs covered for manufacturing and operations.

Supply Chain

Power your supply chain with seasoned experts who know the ropes and the regulations. At QualityHub, we connect you with top-tier professionals who don’t just understand supply chain challenges – they bring risk management, contingency plans, and resilience.

> Find out how QualityHub has staffing needs covered for your supply chain.

Clinical

QualityHub’s clinical pros understand regulated industry’s need for rigorous clinical data. Our carefully vetted professionals ensure compliance with requirements, appropriate study design, and clear interpretation of results, giving your company market authorization confidence and the highest standards of product quality and safety.

> Find out how QualityHub has your clinical staffing needs covered.

Program/Project Management

QualityHub experts bring clarity, compliance mastery, and relentless focus to the management of your regulated company’s programs and projects. They streamline workflows, minimize risks, and keep initiatives advancing and on target.

> Find out how QualityHub has your staffing needs covered for program and project management.

What Our Clients Say About Us.

"The FDA readiness training was tailored to our specific manufacturing site and incorporated local procedures and previous regulatory comments. This targeted approach yielded a greater training impact and understanding."
"The training we received from QualityHub FDA compliance consultants was invaluable in preparing the site for an inspection. This helped establish proper expectations and confidence. QualityHub provided excellent screening, guidance and training for the establishment of the staging room operations, scribes and inspection administrators."
"QualityHub's input in regard to inspection readiness has been very helpful in preparation for that success!"
"The FDA readiness training by QualityHub is a great refresher course. Take the time to polish up and improve your preparedness knowing their knowledge and expertise makes this a worthwhile practice."
"Thanks to QualityHub's input and the mock inspection, our improved tactics and inspection readiness activities really paid off."

Explore Our MediaHub

When Searching for Public Sector Job, Ex-FDAers Should Embrace Regulatory Intelligence, Brush Up On Biz Acumen, Say Experts

Former FDA officials urge ex-agency employees to leverage and translate their regulatory experience into business terms when seeking private-sector roles. They stress that combining FDA knowledge with business acumen increases marketability, staying current keeps skills relevant, and job seekers shouldn’t settle as the right opportunity will align with their long-term goals.

Industry Insiders: Don’t Leave Ethics at Factory Door When Marketing Prescription Drugs, Medical Devices

Industry experts highlight the importance of regulatory, quality, and marketing teams working together to ensure truthful medical product advertising. They also emphasize that regulatory oversight and open communication are essential to protect patients, maintain compliance, and preserve company integrity amid growing FDA scrutiny of misleading promotions.

When Searching for Public Sector Job, Ex-FDAers Should Embrace Regulatory Intelligence, Brush Up On Biz Acumen, Say Experts

Former FDA officials urge ex-agency employees to leverage and translate their regulatory experience into business terms when seeking private-sector roles. They stress that combining FDA knowledge with business acumen increases marketability, staying current keeps skills relevant, and job seekers shouldn’t settle as the right opportunity will align with their long-term goals.

Inspection Horror Stories: Spooky Tales of Unusual FDA Audit Activities That Were More Trick Than Treat

QualityHub Principal Consultant Jaime Santana has seen his fair share of strange FDA inspection scenarios over the many years he’s spent in the MedTech and pharma arenas. He recounts three memorable cases, including an investigator who overstepped by opening drawers in a finance department; a quality director who sparked a multi-day standoff with an investigator over a withheld document; and a quality VP who was secretly tracked with an AirTag to prevent off-hours contact with an investigator.

QHub Insights: 20 Years On, Outcome of FDA v. Utah Medical Still Reverberates, Say Investigator, Lawyer Involved In 2005 QSR Case

Former FDA investigator Lori Carr and Alson & Bird litigation attorney Dan Jarcho share their memories of US v. Utah Medical Products, a landmark GMP case that was won by the manufacturer in October 2005. Despite a laundry list of allegedly violated subsections of the agency’s Quality System Regulation, the safety and efficacy of Utah Medical’s products were never in question. Rather, the FDA’s overarching issue was that it claimed the company wasn’t properly validating its extrusion or injection molding processes, which were key to the manufacture of plastic parts for its products and components.

RIF’d FDA: 4 Tips for Ex-Agency Staffers, Industry as US Gov’t Employees Search for New Roles

Following a sweeping Reduction in Force (RIF) that displaced thousands of US government employees, including many at the FDA, former agency officials are navigating new paths in the private sector. At RAPS Convergence 2025, ex-FDA leaders shared insights on transitioning successfully and fostering stronger collaboration between industry and remaining FDA staff.

Hurricane, Nuclear Meltdown, Pandemic: This Supply Chain Expert Has Seen It All – See Her 4 Tips For MedTech

A veteran MedTech leader has demonstrated exceptional skill in maintaining manufacturing continuity through some of the world's most challenging supply chain disruptions. Through decisive action, creative problem-solving, and a focus on employee well-being, production was sustained even amid widespread logistical breakdowns. Drawing on these experiences, the expert highlights four key strategies for building resilient supply chains.

Engaging With FDA Is Easy As 1-2-3, Former Device Center Leader Says

Medical device manufacturers operating in the highly regulated MedTech sector should engage proactively and strategically with the FDA, advises Sean Boyd, QualityHub's corporate VP and former FDA official. Companies should first contact the appropriate CDRH review team to resolve technical or compliance issues, escalating to management only if needed. Boyd stresses the importance of presenting a clear, complete story that outlines the issue, corrective actions, and timelines – especially when proposing alternative approaches.

QHub Q&A: Expert Advice on Quality Audits, Risk, Design History Files, Post-Market Surveillance From KENX Speaker

QualityHub regulatory expert Rebecca Fuller will lead key sessions at KENX’s MedTech and GMP University, offering practical guidance on risk management, DHFs, post-market surveillance, and internal audits. Her insights aim to help manufacturers avoid regulatory pitfalls and strengthen compliance.

QualityHub Scores Touchdown With New Biz Development VP Austin Griffing

Austin Griffing has joined QualityHub as Vice President of Business Development. With a strong track record in life sciences business growth and team leadership, Griffing brings a collaborative, results-driven approach to help expand QualityHub’s regulatory and quality systems consultancy.