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Good Manufacturing Practices (GMP) Consulting
Artixio's Global GMP experts are well experienced with ICH guidelines, EU GMP & GDP&GACP guidelines, WHO, ISO, US cGMP requirements and other international GMP regulations. They bring rich experience in GMP/GDP/GACP audits and international authority GMP inspections (EU,US, Mexico, Brazil, China, Japan, Russia & others) with more than 2000 executed audits as lead auditors of different products including APIs and FDFs; supply chain management etc.
Types of Audits Supported
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Active Pharmaceutical Ingredients (API)
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Contract Manufacturers (CMO)
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Finished Drug Formulations (FDF)
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Intermediates
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Excipients
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Packaging Material
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Laboratories
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Medical Devices
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Dietary Supplements
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Supplier Audits
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Pre-Inspection Audits
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Remote & Onsite Audits
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Quality Management System (QMS) Gap Analysis
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Regulatory Gap Analysis of GMP Documentation
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Root Cause Analysis & CAPA
Countries Supported

India
China
Thailand
Indonesia
Malaysia
Taiwan
Vietnam
UAE
Israel
Brazil
Europe
USA
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