Quality Management Services

RESQ provides a full range of Quality Management Services covering all functional activities of the clinical trial process: Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).  Our Quality Clinical Laboratory Practices AuditsAssurance (QA) and Quality Control (QC) Auditors provide our Clients with valuable compliance insights and help to ensure trial integrity, meet Regulatory Authority expectations, and protect the welfare and safety of trial subjects. For all audit projects, RESQ provides audit reports to include the level of exposure for non-compliant issues, as well as recommendations for handling audit findings and implementing corrective action plans.

RESQ QA and QC Auditors have Significant Cross-functional Experience … A Key Discriminator
Not only do RESQ Auditors meet stringent educational and experience requirements; they are typically experienced cross-functionally. This combination of depth and breadth provides our Clients with comprehensive compliance assessments across several areas of operation and with a broad perspective.  Our Auditors minimally possess a BS and/or MS in life sciences or a healthcare discipline. We also require at least15 years of hands-on clinical research experience in the biotech/pharmaceutical industry, with additional experience in QA and QC audits. These credentials are comparable, and in many cases, greater than those required by other CROs and FSPs. All Auditors are thoroughly knowledgeable of Good Clinical Practices, 21 CFR 312, ICH Guidelines, and other Regulatory Statutes, as applicable their functional areas of specialty.

What our Clients Say about Us
“Over the past 14 years I have worked with RESQ on numerous projects including database and clinical study report Clinical Laboratory Practices Auditsaudits. The RESQ staff has repeatedly proven professional and adept in their approach ensuring the integrity and traceability of clinical data and documentation. In addition, RESQ has executed site and distribution facility audits both domestic and international on extremely short notice; final reports were clear, concise and very timely.”

David Schlesinger
Senior Vice President Corporate Quality
MannKind Corporation

Read More about RESQ GCP Audit Services Here

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