Advanced Clinical GxP Quality Services ensure compliance and inspection readiness to regulatory and quality standards.
Our foresight helps you plan ahead so that you not only remain in compliance but are optimally positioned for requirements further along in the drug development process. This expert support helps you proactively avoid issues and delays that may result from non-compliance. Our services feature a customized, scalable suite of solutions that ensure compliance with changing global regulations, in addition to systems and validation services that provide quality assurance in clinical trials.
We Support a Variety of Solutions
- Project-specific quality planning
- Project support through individuals and specialized teams, or as the project requires
- Fully outsourced quality infrastructure engagements
Our Quality Services
Audits
- Systems
- Investigator Sites
- Vendors
- Documents
Infrastructure Support
- Quality Planning
- SOP Development
Specialized Consulting
- Inspection Readiness
- Response to FDA Guidance
- Gap Analysis
- Risk Management
Validation
Advanced Clinical provides consulting and staffing services across the full life cycle of validation. Validated systems are critical to avoid regulatory citations and financial penalties. Advancements in technology fuel the need for more efficient analytic systems, increasing the complex responsibilities of ensuring these systems are validated.
Whether large or small in scale, life sciences systems play an equal role in supporting a successful clinical trial. Collaborating with an experienced partner is critical to successful validation.
Our Validation Services
- Verification Engagements
- System-Specific Oversight
- Change Management
- Risk and Gap Assessments
- Project Staffing
