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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

AI Solutions For Pharma (From Regulatory Affairs to Custom Software)

AI Solutions For Pharma

As the technology is reaching its heights, new innovations like AI can...

September 1, 2025
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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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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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Artixio Recognizes Femicura Healthtech as GEMi Grant Winner for Innovative Medtech Solutions

Artixio Recognizes Femicura Healthtech...

Artixio proudly announces Femicura Healthtech as the recipient...

April 7, 2025
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China NMPA Cosmetic Regulations & Requirements

China NMPA Cosmetic Regulations...

The cosmetics market in China has experienced exponential...

April 7, 2025
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Named Patient Program in India (CDSCO)

Named Patient Program in...

The Named Patient Program (NPP) approval process in...

April 7, 2025
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Reprocessing Single-Use Devices in accordance with EU Medical Device Regulations (EU MDR 2017/745)

Reprocessing Single-Use Devices in...

Single-Use Devices (SUDs) are indispensable in the healthcare...

April 7, 2025
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Precision Medicine – Key Players and Pipeline

Precision Medicine – Key...

Precision medicine, with its promise of tailoring treatments...

April 7, 2025
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