QualityHub

In business for more than two decades, QualityHub is a full-service consultancy that serves FDA-regulated industry, primarily manufacturers of MedTech and Pharmaceutical products. Our focus is on client adherence to regulatory requirements, including the FDA’s Quality System Regulation (QSR) for medical devices and Current Good Manufacturing Practice (cGMP) regulations for drugs, among others. QualityHub’s clients are worldwide and range in size from $50M to $40Bn in annual sales. We deploy ex-FDA and ex-industry experts to perform audits and provide consulting in order to teach, coach, and guide clients so they comply with and adhere to regulations and related international standards. Through consulting and auditing, QualityHub assists clients with complex situations that may involve FDA warning letters and corporate letters, product recalls, due diligence, risk management, new product development and launch, FDA legal actions, and other high-risk activities. We also help optimize and improve quality systems. Further, QualityHub lends a staffing hand to in-need clients by offering the services of interim professionals. These hand-picked temporary staff personnel work in various positions within client companies to assist during key projects or when vacancies leave a position open. Such temporary professionals can fill the role of interim Vice President all the way to interim Professional Staffer, and the many important positions in between, such as interim Team Leader, Manager, and Director, to name a few. Contact QualityHub today and learn what our trusted quality and compliance consultants, project managers, and regulatory experts can do for your company.