About QualityHub

QualityHub is compromised of a top-ranked team of compliance professionals, project managers and regulatory experts that know what your company needs in the complex field of compliance. We know how to map your journey and how to guide you successfully to your ultimate destination: FDA Compliance & Successful Healthcare.

QualityHub consultants and principals are former FDA 
and Subject Matter Experts from the device and pharmaceutical industries, and are respected for their high levels of expertise. QualityHub consultants have an average of 15-25 years of Regulatory Experience.

Our team members have proficiency in a wide range of technical areas. These include, but are not limited to: CAPA, Clinical, Complaint Handling, Document Control, Field Actions, Investigations, Laboratories, Management Controls, MDR, Process Mapping, Process Validation, Risk Analysis, Software Validation and Part 11, Performance Scorecard, Stability, Stabilization, Supplier Management, Training, and many other areas.

When you work with QualityHub, consultant CVs will always be provided for your review and approval for every aspect of the work to be performed on your project. Our Clients can request particular consultants, or personnel with a particular educational or technical expertise, and make adjustments to projects underway as they deem necessary.