Quality Management Consulting, Inc. (QMC) provides quality management solutions for the Biotechnology and Pharmaceutical industries. Our team of multidisciplinary industry-leading experts has consistently delivered the most innovative and effective compliance strategies for clients throughout the globe.

Our consultants have the expertise to develop and validate processes, systems, and methods while integrating current GxP compliance strategies to help our clients build quality into their products and processes.

Our firm specializes in handling complex compliance matters to help our clients navigate today's difficult regulatory landscape.

Our areas of expertise include, but are not limited to:

•      Quality Systems Implementation and Management 

•      GMP Quality Assurance 

•      Clinical Trial Management and Oversight 

•      Regulatory Inspections and Inspection Readiness 

•      Vendor and Clinical Site Auditing 

•      FDA 483 and Warning Letter Response and Remediation 

•      Computer Systems Validation 

•      Process and Cleaning Validation 

       Analytical Methods Validation

•      Quality Control Processes