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GxP Audits

How we help with GxP Audits

Halloran conducts virtual or on-site cost-effective GCP, GLP, and GMP audits of sponsor companies, Contract Research Organizations (CROs), Academic Research Organizations (AROs), Contract Manufacturing Organizations (CMOs), Laboratories, Trial Master Files (TMF), clinical sites, and sponsor processes. Our team is experienced in conducting qualification, re-qualification, for-cause, and routine audits across these entities. We partner with our clients to develop risk-based audit plans, identifying immediate and long-term corrective actions and providing recommendations that support continuous improvement and inspection readiness.

RELATED INSIGHTS

  • The International Council for Harmonisation draft guideline, ICH E6(R3), released on May 19, 2023, provides implications for Risk-Based Quality Management (RBQM).  Considering the updates, John Sikora, Associate Principal Consultant at Halloran presented at Momentum’s annual GCP Inspection Readiness conference. John’s presentation, “Examining the Impact of ICH E6 (R3) on RBQM, Oversight Procedures and GCP Inspection […]

  • Are you sponsoring a clinical trial and wondering how to develop an Informed Consent Form (ICF) that best facilitates the informed consent process? If you are, you’re not alone. If you aren’t, you should be. During our webinar, we will review the principles and requirements of informed consent, share common challenges and recommendations in the […]

  • In April of this year, the U.S Food and Drug Administration (FDA) released “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry.”  This guidance is noted to expand on the prior guidance for industry, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring,” released in August 2013 and to […]