GXPQS Expert Consultants have a broad range of experience in developing successful strategies encompassing research, development, clinical trials, and commercialization resulting in speed to market. Our proprietary Quality System includes the assessment of the complete product life cycle and identification of the strategic and execution elements necessary for product approval.
Execution of the strategy:
Not only are our consultants able to provide strategic assistance, but they also contribute to all functional areas of research and development, from early research and development activities to commercialization activities, increasing efficiency and speed to market. They can assist in specific areas for acute issue resolution (i.e. environmental contamination in a manufacturing suite, 483/warning letter responses and resolution, to consent decree remediation), or they can provide targeted guidance for continuous improvement within the QMS. Our consultants have hands-on experience and proven success in all functional areas described on this website.
Comprehensive Quality System/Compliance Plan Development
Research Target Product Profile (TPP) Definition
Development Strategy and Execution
Clinical Trial Plan Development
Commercialization Strategy and Implementation Plan