QualityHub Releases On-Demand Document Consulting to Streamline FDA Regulations

QualityHub, a leader in international consulting and documentation, announces its latest offering for clients: QReview. QReview is an on-demand remote document review and consulting service that equips teams with the expertise they need, when they need it. The subscription-based service pinpoints customers who still have to meet FDA-regulated deadlines while also navigating the hindrances of remote work. 

Inspired by direct feedback from clients, QReview covers a variety of documentation types — Quality, Technical and Regulatory. QReview helps mitigate time and resource constraints, and ultimately gives a higher return on investment than struggling through in-person consultancy. QReview upholds the same standards customers already expect from QualityHub, and it reduces business and compliance risk by improving the quality and clarity of document content. 

As with all QualityHub services, security and confidentiality remain paramount. QReview provides a secure, encrypted means for transferring and storing documents and records on a secure cloud-based platform. When processing subscriptions, QualityHub will establish a client-specific confidentiality and non-disclosure agreement. All of SMEs and consultants have signed confidentiality and nondisclosure agreements that extend from QualityHub to all clients, projects and associated information. The subscription service agreement includes references to the protection of confidential and proprietary documentation.

“The QualityHub team is thrilled to offer QReview to our clients. This year pushed the evolution of remote opportunities into overdrive, and we want to be where our customers are — even if that’s still not in a formal office,” said Rebecca Fuller, QualityHub’s newest Consulting Director. “Regardless of where they are, our partners in medical, pharmaceutical and biologics industries still demand access to high-quality resources. We also believe that transitioning to remote work is more than a trend but a natural progression of a digital environment. We’re giving companies access to experts in a nontraditional, more effective way, all while upholding safe collaborative practices.” 


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.