Artixio

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

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
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

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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