Quality Assurance & Control

Quality Assurance (QA) and Quality Control (QC) help to prevent flaws or errors in both the product and the process and enhance quality consistent with the Sponsor’s goals.

LBR professionals have conducted various types of QA and QC audits including:

  • 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 & IP storage/shipment vendors)

These QA and QC audits have been performed in many different geographies:

  • North America (United States, Canada and Mexico)
  • South America (Brazil & Colombia)
  • Europe (Germany and UK)
  • Eastern Europe (Poland, Czech Republic, Serbia, Romania, Georgia, Russia, Bulgaria, Ukraine, Hungary & Austria)
  • Asia (China & South Korea)
  • India

LBR Program Management and Project Management Services

Quality Assurance Services Include:

Quality Control Services Include: