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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.

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  • This article is based on opinions and perceptions from the DIA 2024 Global Annual Meeting, in San Diego, June 2024. Many thanks to our contributors: April Purcell (Specialist) and Michelle Peter (Senior Specialist). The team sat down with Gail Winslow, Head of Marketing, after the conference to share their experiences.   From start to finish, several […]

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  • Watch Halloran’s Inspection Readiness Webinar Here A Health Authority inspection of a clinical trial can occur at any point during a product’s lifecycle, making adequate preparation essential for a successful inspection and eventual market approval. Unfortunately, sponsors often begin preparing for inspections only when a critical milestone, such as a Biologics License Application (BLA) or […]