Quality Assurance

Over the past ten years LBR staff have conducted various types of QA audits (routine QA site audits, for cause site audits, site inspection readiness audits for FDA/EMA inspections, vendor qualification audits [including IP manufacturing vendors, preclinical providers, clinical laboratories and IP storage/shipment vendors]) throughout the US, Canada and Mexico; South America (Brazil), Europe ( Germany and UK); Eastern Europe (Poland, Czech Republic, Serbia, Romania, Georgia, Russia, Bulgaria, Ukraine, Hungary and Austria), Asia (China and South Korea); India; Australia and New Zealand.

LBR Quality Assurance provides the following services:

• Clinical site audits
• Database audits
• Site qualification/audits
• For-Cause audits
• Clinical Study Report audits
• Submission (IND, INAD, NDA, NADA, etc.) audits
• Quality Systems audits
• Site inspection readiness audits