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A BOLD REVOLUTION


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A BOLD REVOLUTION


 

The QxP team is comprised of executives with extensive track records delivering successful outcomes in situations of intense regulatory scrutiny.  Our executives have substantial experience interacting and negotiating with FDA and other global regulatory agencies.  We take a pragmatic, strategic view of internal processes, quality system development, and implementation of key matters.  Our approach is to “do and teach.”  We assist our clients in developing Quality and Compliance organizations and leaders, all while getting real work done.

 

WE ARE

·       Executive Quality Leaders

·       Successful Change Leaders

·       Compliance Experts across all GMP Aspects

·       Technical Experts in:

o   Aseptic processing

o   Analytical chemistry

o   Microbiology sterility assurance

o   Engineering operations

o   Process validation

o   Cleaning validation

o   Computer validation

o   Method validation

o   Manufacturing

·       Strategic Experts who provide tactical solutions for significant compliance and product issues in parenterals, solid oral dosage, biotech, vaccines, medical devices, and animal health

 

 

Crystal Mersh, CEO and Executive Partner

Brian Duncan, V.P. of Engagement Operations

Nicole Monachino, General Counsel and V.P. of Business Operations

Rebecca Brewer, Strategic Practice Lead

Bob Ferer, Strategic Practice Lead