We are committed to Quality Assurance

Quality is a key priority and of the utmost importance at Navigate BioPharma. Every associate is committed to providing high quality service in compliance with applicable federal, state and local laws and regulations, so you always have confidence in your data.  

Quality is an integral part of every department at Navigate BioPharma with a focus on continuous improvement and a commitment to excellence. Our BioPharma’s Quality Systems are designed and maintained to:

  • Assess and continuously improve the delivery of services to meet the needs of patients and sponsors of clinical trials for drug and diagnostic applications
  • Evaluate and improve the reliability, efficiency, and quality of our services
  • Identify, and minimize sources of errors, problems, and complaints
  • Provide a mechanism for corrective and preventive actions
  • Assess and ensure the effectiveness of our policies
  • Ensure the adequacy and competency of our staff
  • Ensure the integrity of our data
  • Ensure compliance with applicable regulatory requirements for drug and diagnostic approvals, including CLIA, Good Clinical Practice/Good Clinical Laboratory Practice (GCP/GCLP), Good Manufacturing Practices (GMP), and Quality System Regulations (QSR)

Navigate BioPharma has CLIA (Clinical Laboratory Improvement Amendments) accreditation for high complexity testing through CMS (Centers of Medicare and Medicaid Services) and participates in the College of American Pathologists (CAP) Laboratory Accreditation Program.

Navigate BioPharma also maintains current licensure required by state and local regulations.


Navigate BioPharma Accreditations

Navigate BioPharma is CAP/CLIA accredited along with specific state licensed: CA, NY, PA, MD, RI and FLA.

CAP/CLIA accreditation was last received in November 2022 and on-site review is conducted every two years. Additionally, we follow GCLP and GMP quality systems as needed, and have a California GMP license.

The FDA conducted a successful bioresearch monitoring (BIMO) inspection of our facility in January 2017 for a companion diagnostic program where Navigate BioPharma supported the clinical and analytical validation. The inspection supported the PMA for the first molecular NGS assay submitted to the FDA medical device division.  We also have routine sponsor audits for FDA preparation in support of registration AL pivotal endpoints.

Please contact our team to schedule a sponsor audit.