If you need a road map or help along the way, we can help.

We have made training and consulting the cornerstones of our business. We believe they are the key ingredients to achieving quality practices. Whether you are reacting to a recent FDA Warning Letter, as many of our clients are, or proactively seeking assistance, QualityHub™ can craft a solution for your organization.

Based on the popularity of our temporary Quality Manager program we have expanded this program to include other temporary positions to the regulated industry. Aside from temporary Quality Managers, we also provide temporary Quality Engineers, Audit Program Managers and Auditors. We can also provide temporary staff in QA, Regulatory Affairs, MDR and Complaint Management, Design Assurance, Laboratory Programs and CAPA Management. Inquire if you need help in those or other areas.

While many companies seek to establish and maintain the highest quality practices proactively, others seek those goals in a more urgent manner, either just before, or just after an FDA experience. Our clients come to us from both ends of that spectrum. We work with companies who are proactive, as well as those companies currently facing FDA challenges.

Our work is centered on making your organization successful. From specific GMP related items to general GMP training or more complex quality system implementation efforts, we are focused on your organizational needs. We perform company wide analysis, training, consulting and auditing.

Our associates are highly experienced in all phases of quality system/GMP such as validation, auditing, CAPA, management controls, document control, change control, design control, and production/process control. We work with top management in doing it right the first time - from the initial gap analysis to the implementation and continuous improvement. We can help develop compliance master plans and FDA update submissions. Our associates also provide project management, which is vital to providing metrics and oversight to the projects. We also can assist in your culture change and communication efforts.