QualityHub, Inc. Information

QualityHub is a consulting organization that serves the FDA regulated industry, primarily manufacturers of Medical Devices and Pharmaceuticals. Our focus is on client adherence to FDA regulations, particularly the Good Manufacturing Practices (GMPs) and/or Quality Systems for Medical Devices and Pharmaceuticals. Our clients are worldwide, and range in size from $50 Million to $40 Billion in annual sales. We use ex-FDA and ex-industry experts to perform audits and provide consulting in order to teach, coach and guide our clients into the understanding and implementation of the various FDA legal requirements. Through consulting and auditing, we assist clients with complex situations that may involve FDA Warning Letters, 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. Additionally, we service our clients by providing Interim Professionals (IP). The IPs are temporary staff personnel who work in various positions in the companies to help out during key projects, or when vacancies leave a position open. The IP can fill the roles of Interim Vice President all the way down to interim Professional Staffer, and numerous positions in-between, such as Interim Team Leader, Interim Manager and Interim Director.