Ensuring Regulatory Compliance with Independent Audits
We offer comprehensive Third Party Audit Services to ensure that your clinical trials, bioanalytical processes, and documentation meet the highest standards of quality, compliance, and regulatory requirements (FDA, EMA, ICH).
Our unbiased, expert auditors provide the critical assessment needed to identify gaps, mitigate risks, and ensure submission readiness, acting as a trusted external review partner.
Key Areas of Our Third Party Audit Services
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GxP Audits (GCP, GLP, GMP)
Independent assessments to ensure full compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) standards across all phases of your research.
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Clinical Data Audits
Verification of the accuracy, completeness, and integrity of clinical trial data. This includes reviewing source documents, Case Report Forms (CRFs), and Clinical Data Management Systems (CDMS).
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Regulatory Compliance Audits
Thorough review of trial documentation, protocols, and regulatory submissions to ensure adherence to global regulations, including FDA, EMA, and ICH guidelines. Essential for pre-inspection readiness.
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Process Audits & QA System Review
Evaluation of operational workflows, including site management, patient recruitment, and SOPs. Identifying inefficiencies and areas for improvement in your Quality Assurance system.
As experienced 3rd party audit companies, MTRL provides objective insights critical for risk mitigation. Our reports offer clear, actionable recommendations to correct findings, ensuring your studies can withstand the scrutiny of regulatory bodies worldwide.
Partner with us for your third party audits to protect your investment and accelerate your path to regulatory approval.
Schedule Your Regulatory Compliance Audit Today
Ensure your clinical trials are fully compliant and submission-ready with an independent MTRL audit.
Contact Our Audit Experts