GxP Services
Make Quality Your Competitive Advantage
Advarra Consulting provides industry-leading, end-to-end Good x Practice (GxP) quality solutions for the rapidly changing life sciences industry. As value chains extend around the globe and regulations evolve, the need to maintain and optimize all aspects of quality management systems has become more critical.
Tailored Offerings
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 compliance 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.
- Audit preparation, execution, and remediation
- Conduct individual and/or build multiple audit programs
- Broad-based GxP audits including GCP, GLP/GcLP, IT/CSV, and internal assessments
There is immense value in the work that Advarra conducted for us on this project. We could have not reviewed thesignificant 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
Proactively identify risks, navigate required inspections with confidence, and move quickly to resolve costly, time-sensitive issues.
- U.S. and global health authorities 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
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.
A Snapshot of our GxP Expertise
Joan Versaggi, MBA
Managing Expert, Advarra GxP Services
Amanda Bourgeois, BS, MS
Director, GxP Services
Jay Westfall, BS
Director, GxP Services
Leanne Parshall, BS, MS
Associate Director, GxP Services
Kristine Khachatryan, BSc, MSc
Associate Director, GxP Services
Tammy Moederzoon, BS
Consultant
Dawn Wydner
Former FDA Consumer Safety Officer, LCDR
Steffen Engel, PhD
Managing Expert and Former Executive Director Analytical Development at West-Ward Pharmaceuticals
“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
Related Resources
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.
Ace Your Next FDA Inspection
Discover valuable insights and expert guidance on navigating FDA inspections in clinical research.
NIH 2023 Data Management and Sharing Policy: What you Need to Know
Optimizing Your Data Management Plan: Best Practices for Biomedical Research under the NIH Data Sharing Policy
