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Quality Center of Excellence

Make Quality Your Competitive Advantage

Advarra Consulting provides industry-leading GxP quality solutions for the rapidly changing life sciences and consumer products markets. Through our Quality Center of Excellence, we help clients deliver safe and reliable products to billions of consumers around the world.

Tailored Offerings

Proactively identify risks, navigate required inspections with confidence, and move quickly to resolve costly, time-sensitive issues.

  • FDA and EMA inspection readiness assessments and preparation
  • Mock inspections – sponsors and investigative sites
  • Function and individual coaching in preparing for and responding to health authority questions
  • Post inspection remediation

I have to give you credit for the make-up and chemistry of the team. That doesn’t happen by accident. The combination of all their perspectives really made a tremendous difference.
– Global Head of R&D

Build, develop, or optimize your quality management system to drive superior outcomes.

  • Help and support with understanding the QMS context
  • Process assessment and gap analysis
  • Drive continuous improvement
  • Documentation, resources, and process support
  • Issue and knowledge management
  • Management review and QMS assessments

The deliverables provided were best in class and the way Advarra partnered with us was extremely professional and valuable.
– VP, Development Operations

Conduct a broad range of GxP audits to identify and resolve issues quickly and provide a systematic assessment across programs or functions.

  • Build out and conduct individual or multiple audit programs
  • Broad based GxP audits including: GCP, GLP/GcLP, GMP, IT/CSV, and GVP

There is immense value in the work that Advarra conducted for us on this project. We could not have reviewed the significant volume of data that needed assessment as quickly as the Advarra team. They did an exemplary job in reviewing the data and identifying the risk areas that we need to focus on most going forward.
– Client’s Director, Quality Process Lead

Let Our Experience Be Your Advantage

Quality people build quality systems. Advarra’s quality leadership is made up of practitioners with decades of experience building quality systems for leading Fortune 500 companies.

We work with a network of seasoned QA practitioners, engineers, scientists, clinicians, and technicians who understand your challenges and partner to deliver customized solutions to fit your unique needs.

We use our extensive experience developing and utilizing industry best practices to bring practical, risk-based thinking to our client organizations, ensuring everything from strategy to execution delivers the solutions needed to improve and maintain performance.

Joan Versaggi, MBA
VP & Principal, Quality CoE

Former Director—Research Laboratories Program Realization Office-Sigma, Merck

Joan leads a diverse team of quality experts offering their in-depth experience and knowledge across GxPs to deliver solutions in quality strategy and management, inspection readiness, training, and audits to ensure quality and compliance across the clinical ecosystem.

A Snapshot of Our Quality Expertise

Arti Bajpai
Former Sr. Director of R&D Compliance & Process at Shire

Anthea Dransfield, BSc, MSc, CChem, MRSC
Managing Director, Advarra Quality Center of Excellence
Former Sr. Director of Quality Management at ProSciento, Inc

Claudia Malcolm, MSc, MRQA
Managing Director, Advarra Quality Center of Excellence
Former Sr. Clinical QA Manager at ICON

Steffen Engel, PhD
Former Executive Director Analytical Development at West-Ward Pharmaceuticals.

Peter Marks
Former Head of Quality & Continuous Improvement at Merck Sharp & Dohme Corp.

Liz Wool
Former Global Head of Training at Barnett International, Inc.

Dawn Wydner
Former FDA Consumer Safety Officer, LCDR

Penelope Przekop
Former Senior Director of Global Quality Assurance & Training at Theradex Systems

“There is immense value in the work that Advarra conducted for us on this project. We could not have reviewed the significant volume of data that needed assessment as quickly as the Advarra team. They did an exemplary job in reviewing the data and identifying the risk areas that we need to focus on most going forward.”

Client's Director

Quality Process Lead

“The deliverables provided were best in class and the way Advarra partnered with us was extremely professional and valuable.”

– VP, Development Operations

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