QualityHub has made a strategic investment to accelerate growth by merging with longtime strategic partner, BioAssist Consulting Services. 

ORLANDO — International Consulting Firm, QualityHub, Inc. has joined forces with BioAssist Consulting Services. BioAssist has been a strategic partner with QualityHub for over 15 years. 

“BioAssist has consistently proved to be a top FDA Consulting group with highly regarded consultants that can handle the most complex FDA related compliance projects,” said Tim Wells, QualityHub founder, said. “We welcome them to QualityHub.”  

Wells continued: “We are excited about the merger because the partnership will enable us to implement new services. In fact, some of those new services will be launched this summer. Additionally, the merger will strengthen our base of top personnel and help us incorporate best practices into our auditing and consulting services.”

The merger will strengthen QualityHub’s expertise in several key areas: Regulatory Submissions, Complaint Handling and Adverse Event Reporting, Design Controls and Risk Management.  This partnership will also increase QualityHub’s capabilities in the Pharmaceutical and Combination Product sector.

Since 2004, QualityHub has served as an industry leader in the area of FDA Quality System Compliance. With clients worldwide in Medical Device, Pharmaceuticals and Combination Products, QualityHub is recognized in FDA circles, including FDA related law firms, as a go-to company for auditing, certifications, as well as handling FDA-483, Warning Letter and Consent Decree related projects. FDA recognized remediation projects are one of the primary services of QualityHub. With the growth of their Interim Professional program, QualityHub has also become a leader in providing interim staffing in complaint handling/MDR, validation, supplier activities and design control/risk management related activities.

For assistance with FDA inspections or related FDA actions, as well as audits, remediation, and interim staffing please contact QualityHub at info@qualityhub.com or call 407-896-3386.