Services include both routine (i.e. chemistry, immunology/serology, microbiology, hematology, and blood bank) and specialized testing (i.e.toxicology, molecular pathology, pharmacogenetics, histocompatibility/immunogenetics (HLA), and molecular microbiology).

Advise on general clinical laboratory compliance, including Quality Management System (QMS) development and operational best practices.

Provide strategic input on timelines, planning, and implementation activities of laboratory operations on Laboratory-Developed Test (LDT) and FDA cleared test.

Complete preparation and submission of regulatory applications for CLIA, CAP, California State, New York State, ISO 15189, and other relevant agencies.

Comprehensive support the full lifecycle of assay implementation from test selection to validation, documentation, and compliance ensuring smooth and successful assay implementation.

Prepare your lab for inspections through mock audits, readiness assessments, and ongoing compliance maintenance.

Create and review SOPs across pre-analytical, analytical, post-analytical, and general laboratory operations.

Recruit and evaluate qualified personnel—including lab director, clinical consultant, technical consultant/supervisor, and testing personnel—in alignment with regulatory and testing complexity requirements.

Assess technical and operational workflows to enhance efficiency, reduce costs, and ensure regulatory compliance.

Design, develop, establish, and maintain a QMS that complies with all applicable regulations and standards.

Identify compliance gaps and implement effective corrective and preventive actions to ensure inspection readiness and sustained compliance.

Identify and support quality monitoring and improvement initiatives to enhance lab performance and regulatory compliance.