Good Manufacturing Practices (GMP) Consulting Services
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.
Services We Offer
Types of GMP Audits Supported
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.
Active Pharmaceutical Ingredients (API)
Dietary Supplements
Contract Manufacturers (CMO)
Supplier Audits
Finished Drug Formulations (FDF)
Pre-Inspection Audits
Intermediates
Remote & Onsite Audits
Excipients
Quality Management System (QMS) Gap Analysis
Packaging Material
Regulatory Gap Analysis of GMP Documentation
Laboratories
Root Cause Analysis & CAPA
Medical Devices
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Specialized Pharmacovigilance
Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Regulatory Affairs Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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