Areas of Expertise | Laboratory Quality

Areas of Expertise/Services

Quality Assurance

Proficiency Testing Requirements
Quality Assessment Program
Quality Manual Development
Author Quality SOPs
Quality Management System Frameworks and Applications
Employee Qualification

Regulatory Affairs

Inspection Citation Correction and Responses
Internal Audits
Regulatory Compliance for Diagnostic and Clinical Trial Laboratories
Regulatory Applications and Submissions

Licensing and Accreditation

Initial Licensing and Accreditation Applications and Maintenance
Inspection Preparation and Inspection Day Support
State and Federal Requirements

Project Management

Method Verification and Validation Requirements
QMS Platform qualification, installation and implementation
Process Improvement Projects
Digital Health Laboratory Workflow
At - Home Testing
Assay Development

High-Complexity Testing Requirements

Precision Medicine
Laboratory Developed Tests CLIA, NYSDH and FDA requirements
Molecular Methods
Quality Control
Clinical Trials Testing
CLS Review and Reporting of Test Results

Laboratory quality consultant, CLIA, CAP, Laboratory licensing, laboratory accreditation, medical device, clinical trials, data analysis, quality control, quality assurance, laboratory start-up, part-time quality, quality projects, quality improvement, quality support, inspection preparation, citation correction, citation response.