Quality

Navigate BioPharma’s Commitment 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.  
Quality is an integral part of every department at Navigate BioPharma with a focus on continual improvement and a commitment to excellence.  Navigate 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 Navigate BioPharma services.
• Identify, and minimize sources of errors, problems, and complaints.
• Provide a mechanism for corrective and preventive actions.
• Assess and ensure the effectiveness of Navigate BioPharma policies.
• Ensure the adequacy and competency of 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).

Licensure and Accreditations

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.