Consulting
GxP Services
Integrating quality into each stage of the clinical trial lifecycle ensures faster timelines, better risk management, and enhanced regulatory compliance. Advarra’s GxP services provide comprehensive support tailored to the unique needs of your trial, from startup through closeout, helping you deliver innovative therapies to patients worldwide.
Core Offerings
- Quality management system
- GxP audits
- Health inspection readiness
- Process Assessment
- Mock Inspections
Make Quality Your Competitive Advantage
Tailored Solutions
Advarra offers customized solutions for clinical trials, supporting clients with audits, quality management, and compliance across the globe.
Proactive Risk Mitigation
Systematic assessments help address quality risks and accelerate timelines.
Inspection Readiness
Complete readiness for U.S. and global health authority inspections, including mock inspections.
Global Expertise
Extensive experience with audits and GxP projects in over 75 countries and across six continents.
Proven Impact
Advarra performs over 7,000 GxP projects annually, including good clinical practice (GCP), good laboratory practice (GLP), good manufacturing practice (GMP), and computer system validation (CSV) audits.
Support Across The Lifecycle
Startup
- Process assessment and gap analysis
- Audit preparation and execution
- Global inspection readiness
Conduct
- Data management
- Compliance support
- GxP audits (site, vendor, sponsor)
- Mock inspections for sites/sponsors
Closeout
- QMS assessments and post-close activities
- Post-inspection remediation
- Internal audits and coaching for compliance
Testimonials
The deliverables provided were best in class and the way Advarra partnered with us was extremely professional and valuable.
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.
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.
