Regulatory Compliance

Compliance Made Simple and Easy

Clinical Lab Consulting: Unlimited Laboratory Resources and Expertise.

Clinical laboratories operate in a constantly changing environment. Rules, regulations, and laws that laboratories must follow, drive much of that change. Today’s laboratory managers and directors must spend significant time and effort ensuring that their laboratory remains compliant. Clinical Lab Consulting (CLC) is positioned to help. Our team of consultants are experts in the field of Clinical Laboratory Science, are employed with well know clinical laboratories, and have a record of accomplishment for developing some of the most successful clinical laboratories in the country. These experts are active contributors in the field, are highly published, and have helped established industry wide standards in CLIA and CAP Molecular Diagnostics regulations.

Clinical Laboratory Consulting can help in:

  • Quality Management Development
  • Selection and Implementation of Equipment and Procedures
  • Development of FDA or non-FDA approved assays
  • Assay Validation and Assay Verification
  • Test Report Development and Interpretation
  • Proficiency Testing Program Development
  • Assay Quality Control Program Development
  • Laboratory Pre-Inspection (Preparation for Inspection, Mock Inspection)
  • Laboratory Safety Program Development (Safety Management Plan)