TOTELL
Pre-Clinical & Early Phase Clinical Development Solutions in the Heart of BioBeach
Quality Control & Quality Assurance
Quality Control (QC) and Quality Assurance (QA) are indispensable in clinical development, underpinning the safety, reliability, and regulatory compliance of clinical trials and the drug product. They ensure patient safety, enhance data integrity, improve trial efficiency, and build stakeholder trust, ultimately facilitating successful market approval and commercialization of new therapies.
Our quality veterans bring a wealth of expertise in implementing robust QC and QA systems, conducting thorough audits, and providing continuous monitoring and improvement strategies.
QA/QC
Product and Process Validation
Data Integrity
Risk Management
Due Diligence
Expert Witnesses
Regulatory & GxP Compliance
Audits & Inspections
GxP Auditing
(GCP, GLP, GMP, GDP, GVP, GCLP, etc.)
Internal Audits
Vendor Audits
Inspection Readiness
Mock Inspections
Quality Management System (QMS) Development & Implementation
QMS Gap Assessment
QMS Design & Integration
Clinical Quality Management System (CQMS) Development & Integration
Standard Operating Procedure (SOP) Development & Implementation
Continuous Improvement Initiatives
Root Cause Analyses
Corrective and Preventive Actions (CAPA) Implementation & Management
Establishing & Monitoring Quality Metrics & Key Performance Indicators (KPIs)
Vendor Oversight
Contract Research Organizations (CROs)
Contract Manufacturing Organizations (CMOs)/Contract Development & Manufacturing Organizations (CDMOs)
Academic Research Organizations (AROs)
Contract Labs
San Diego, CA info@Totellinc.com
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