1125 Boone Aire Road,
Florence, KY 41042
Call (859) 426-5035

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