Artixio

Global Regulatory Strategies & Expert Insights

Explore a wealth of strategic and practical insights from Artixio’s global regulatory, safety and market access teams with proven cross-functional industry experience. Discover regulations and guidelines from global health authorities, case studies, best practices and handy tips for your success in global markets.

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Articles On Pharmaceuticals

Computer Software Assurance(CSA) In Pharma & Medical Industry

Computer Software Assurance(CSA) In

Under 21 CFR part 11, it is required to validate the electronic...

July 28, 2025
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Pharma Manufacturing Booms in Hidalgo, Mexico

Pharma Manufacturing Booms in

Once overlooked pharma hub in Mexico's Hidalgo region has gained importance with...

June 18, 2025
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Corrective and Preventive Actions (CAPA) In Pharmaceuticals

Corrective and Preventive Actions

In pharmaceuticals research, production and marketing there may be errors from the...

April 10, 2025
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Pharmaceutical Excipients: Definition & Types

Pharmaceutical Excipients: Definition &...

The main component of a drug product is...

April 8, 2025
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What Is Investigational New Drug & Types Of IND

What Is Investigational New...

The governing federal law makes it a compulsion...

April 8, 2025
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Artificial Intelligence Impact on Global Pharma Regulatory Affairs

Artificial Intelligence Impact on...

Artificial Intelligence (AI) has been making significant strides...

April 8, 2025
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COFEPRIS Product Classification Consultation for Food Supplements in Mexico

COFEPRIS Product Classification Consultation...

Navigating the regulatory landscape when introducing food supplements...

April 7, 2025
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Updated List of Approved Fixed-Dose Combinations (FDC) from CDSCO, India

Updated List of Approved...

The CDSCO serves as the main authority regulating...

April 7, 2025
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COFEPRIS Regulation of Nitrosamines in Pharmaceuticals in Mexico

COFEPRIS Regulation of Nitrosamines...

Nitrosamines have emerged as a significant concern in...

April 7, 2025
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COFEPRIS Prior Sanitary Import Permit for Food Supplements in Mexico

COFEPRIS Prior Sanitary Import...

Introducing food supplements into the Mexican market requires...

April 7, 2025
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Mexico (COFEPRIS) Regulations For Medical Device Registration

Mexico (COFEPRIS) Regulations For...

The healthcare sector, being a dynamic and rapidly...

April 7, 2025
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Notice of Operation: Essential Pre-requisite for registration of products with COFEPRIS, Mexico

Notice of Operation: Essential...

A Notice of Operation in Mexico, or Aviso...

April 7, 2025
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