WE PROVIDE

QxP partners with clients throughout Asia, Europe, and North America across the life sciences platform to provide

·       Remediation Services

o   Strategic advice to address 483 observations and avoid further regulatory action

o   Warning letter and consent decree management, including:

§  Transformation plan development

§  Management controls assessments

§  Execution planning and support

§  Verification and oversight

§  Stakeholder communications

§  Independent third party expert services

·       Support for FDA and Global Regulatory Agency Inspections and Readiness Activities

·       Enterprise Quality and Compliance Risk Assessments

o   Quality System Assessments and Maturity Rankings

o   Educational programs and execution strategies to enable sustainability

o   Development and implementation of global standards

o   Data Integrity Assessments

·       Product Assessments and Corrective Action Plans

·       Executive Leadership Support

o   Quality advisor to executive boards

o   Executive coaching and support for individuals and teams

o   Integrating Quality planning with business objectives

·       Organizational Assessments, Design, and Development

·       Global Strategy Development and Deployment

o   Benchmarking

o   Enterprise strategy development

o   Mergers & Acquisitions support

o   Quality innovation and thought leadership

 

WE OFFER

QXP’s extensive tool kit provides consistent, comprehensive, and robust delivery of services.  We can also customize tools for your use, including

·       Data Integrity Assessments

·       Gap Assessments

·       Structured Product Assessments

·       Organizational Assessments

·       Management Controls Assessments

·       Evaluations of Investigations, CAPA  Adequacy

·       Development of Quality Standards

·       Effectiveness Checks