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.
David Marks
VP & Principal, Quality Center of Excellence (COE)
David provides executive strategy and direction for all GxP quality-related services as well as leads strategic collaboration across other Advarra Consulting Centers of Excellence (Clinical, Regulatory, Institutional Research).
As Senior Vice President, PRA Health Sciences (now ICON) David has worked across the clinical development space with companies such as Solstice Neurosciences, Shire, GlaxoSmithKline, and PPD. In his decades-long experiences in research and development, David has mentored and supported general managers, as well as had oversight responsibility for global quality and training, and process management. David has a BBA in Marketing from Southwest Texas State University.
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
Joan Versaggi, MBA
Managing Expert, Advarra Quality Center of Excellence
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
Related Resources
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
Is Your Site Ready for an FDA Inspection?
Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
