Bioanalytical Laboratory Audits

(GCP and GLP)

QC2 offers the following GCP and GLP bioanalytical laboratory audits:

Large and Small Molecules

Audits of bioanalytical laboratories, a unique specialty of QC2, to assess systems and facilities for compliance with study pharmacokinetic (PK) and toxicokinetic (TK) requirements, Standard Operating Procedures, the FDA Guidance For Industry: Bioanalytical Method Validation, May 2001, and 21 CFR Part 11 (as well as EMA Guideline on Bioanalytical Method Validation, February 2012, as applicable).

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 FDA Guidance For Industry: Bioanalytical Method Validation, May 2001, and 21 CFR Part 11, as well as facility Standard Operating Procedures.

QC2 audits are customized for your specific project and budget needs.  We can provide assistance with all aspects of your projects, including audit plan consulting and development, audit scheduling, conduct, and reporting, and audit follow-up services (e.g., review of audit responses).  We conduct both general qualification audits and in-study audits. Many of our audits can be conducted remotely, helping our clients to maintain their audit programs during this unprecedented time.