Bioanalytical Laboratory Audits

QC2 offers the following GCP and GLP bioanalytical laboratory audits:

Large and Small Molecules

Audits of bioanalytical laboratories, a unique specialty of QC2, are conducted to assess systems and facilities for compliance with 21 CFR Part 11, 58, and 320, Standard Operating Procedures, and the International Conference on Harmonisation M10 Guideline: Bioanalytical Method Validation and Study Sample Analysis (May 2022).

Biomarkers

Biomarker discovery and detection are typically conducted at esoteric testing laboratories and do not fall under any specific guidances or regulations. QC2 will assess systems and facilities for compliance with applicable aspects of the International Conference on Harmonisation M10 Guideline: Bioanalytical Method Validation and Study Sample Analysis (May 2022), 21 CFR Part 11, as well as facility Standard Operating Procedures.

Celebrating 30 Years of Excellence in GCP and GLP Auditing

This year we proudly celebrate 30 years of excellence in GCP and GLP auditing.

For three decades, our team has partnered with sponsors, CROs, and clinical research sites to ensure the highest standards of quality, compliance, and patient safety. From paper-based trials in the 90s to today’s complex global studies powered by advanced technologies, we’ve remained committed to integrity, precision, and continuous improvement.

Over the years, we’ve:

✔ Conducted thousands of audits across the globe
✔ Supported regulatory readiness and successful inspections
✔ Helped strengthen quality systems for organizations of all sizes
✔ Built lasting partnerships grounded in trust and expertise

This milestone is not just about longevity—it’s about impact. It’s about our dedicated auditors who have worked tirelessly to uphold the standards that protect research participants and ensure credible data.

To our clients: thank you for being part of our journey. Your collaboration and dedication to quality make everything we do possible.

As we look ahead, we remain focused on evolving with the clinical research landscape, embracing innovation, and continuing to raise the bar in GCP and GLP auditing.

Here’s to the next 30 years of quality, compliance, and advancing clinical research together.

Quality and Compliance Consulting, Inc.

GCP Audits · Sponsor, CRO, and Vendor Audits · GLP Audits · Central Lab Audits · Bioanalytical Lab Audits · CSV Audits · Consulting · Training · Standard Operating Procedures

Bioanalytical Laboratory Audits

Large and Small Molecules

Biomarkers