Clear insight into compliance, quality systems and data reliability.
Global Pharma QA Ltd provides independent, risk-based audits tailored to your needs, the activities being assessed and the applicable requirements.
You receive a high-value quality and compliance service that identifies risks to your studies/processes, delivers improvements, while auditees strengthen their processes and quality culture, creating a true win-win outcome for all stakeholders.
We specialize in GXP Audits, Globally:
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Animal Facility Audits and critical in-life study procedures (GLP, Non-GLP).
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Laboratories Audits, analyzing non-clinical/clinical samples (GLP/GCLP including Archive facilities).
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Non-Regulated / University Labs audits for Good Practice, reviewing non-regulated/university labs and analyzing samples to ensure compliance with good practice standards and the reliability of study data.
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Pharmaceutical Manufacturing Audits (GMP)
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Clinical facilities and trails Audits (GCP)
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Pharmacovigilance (PV)
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Computerised Systems (IT): Validation, Data Integrity, Data Flow, Artificial Intelligence (AI) tools.
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FDA Mock inspections by ex-FDA inspector
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Remote Audit Methodology 💡 simple, effective, and powerful - when done right.
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Specialized in sensitive For-Cause Audits.
We find and contract the GXP professional auditor that best suits your needs, language and location.
We offer flexibility in our approach, utilizing either the Global Pharma QA platform or your SOPs/Templates to meet your specific requirements. Whether you need assistance in developing and delivering a comprehensive Risk-Based Yearly Audit Program or guidance on particular aspects of your Quality System, we are here to support you in achieving excellence in regulatory compliance.
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