Compassion. Commitment. Competence.
“We take our role as advisors to the Medical Device and Pharma Industries seriously. We know there is a lot at stake, and we know our own reputation rides on it. In many cases our name is used to advise FDA of the strategic and tactical role that we are playing to bring about compliance.” Tim Wells, Founder – QualityHub, Inc
What sets us apart as a company is our passion for doing the right thing. QualityHub brings together like-minded professionals who believe that compliance is more than a hollow set of procedures and policies. It’s much more than a certificate hanging in the lobby. Compliance involves buy-in. It’s a religion of sorts, that must be practiced day in and day out. It’s driven by senior leadership and executed throughout the organization.
We work with companies large and small all over the world in order to help them get into or stay in compliance with FDA requirements. Our reputation as a leader in compliance comes from our comprehensive Quality System audit program but we are much more than an auditing company. We have played a major role in establishing strategies to address Quality System compliance gaps that FDA has pointed out to companies through FDA-483s, Warning Letters, or Consent Decrees. Our services include finding the gaps, developing the needed strategies to remedy the gaps, and helping to execute on those strategies. And, our Interim Professionals program helps our clients to rapidly fill gaps in their organization with highly-skilled industry experts.
Originally known as Wells and Associates, the company was reborn in 2004 as QualityHub. The goal of QualityHub was to be a one-stop-shop for all types of compliance and quality-related expertise. It was the involvement of QualityHub in several high-profile compliance projects in the mid to late 2000s – working with our clients’ corporate and site leadership and FDA – that put QualityHub on the map.
Our focus in recent years has been to further expand our base of consultants and the creation of our Interim Professionals program. We have developed a supplier program that screens potential consultants and zeros in on the most talented personnel. Our mentoring and monitoring of the consultants ensures that the strongest individuals – the top performers – get assignments, and the Clients can rest assured that we have done the necessary ‘weeding out’ of consultants. By constant monitoring and actively obtaining feedback from our Clients, we can be more efficient on the Client projects.
It’s the utilization of quality principles that we impose on ourselves that separates us from the competition. Our team members are seasoned, tried, tested, and proven.
We provide Consultants with expertise in several technical areas: Product Development – including Design Controls & Risk Management, CAPA, Complaint Handling & Reporting, Production & Process Controls – including Process Validation & Computer Software Validation, Supplier Controls, Internal Auditing, Management Controls, Document Control, Drug GMP, Clinical Compliance, and Training.
We can assist companies with FDA 483s and Warning Letters in a number of ways. These include helping prepare the responses to FDA and also the strategies. We can bring in the needed expertise to execute on the strategies and also manage the projects. We utilize several consultants who are ex-FDA Compliance Managers to check that the work being done meets FDA expectations.