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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US Agent Responsibilities & Importance For FDA Regulatory Success

US Agent Responsibilities &...

The United States Food and Drug Administration (FDA)...

March 24, 2025
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Medical Device Regulations and Registration In UK (MHRA)

Medical Device Regulations and...

Medical Device Regulations and Registration Process in the...

March 24, 2025
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UKRP Responsibilities for Medical Device Manufacturers Outside the UK

UKRP Responsibilities for Medical...

For medical device manufacturers located outside the United...

March 24, 2025
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MHRA Pharmaceutical Regulations and Registration in the UK

MHRA Pharmaceutical Regulations and...

In 2024, the Pharmaceuticals market in the United...

March 24, 2025
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Nutraceutical Registration and Regulations in the UK (MHRA)

Nutraceutical Registration and Regulations...

The global nutraceutical industry has experienced remarkable growth...

March 24, 2025
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Global Regulation of Cultivated Meat

Global Regulation of Cultivated...

Cultivated meat is changing the future of food....

March 24, 2025
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PADER In Pharmacovigilance: How To Prepare?

PADER In Pharmacovigilance: How...

PADER (Periodic Adverse Drug Experience Report) is one...

March 24, 2025
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Nutraceutical Regulations and Registration in Colombia (INVIMA)

Nutraceutical Regulations and Registration...

The Colombian nutraceutical market is likely to continue...

March 24, 2025
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What Is a Marketing Authorization Holder (MAH)?

What Is a Marketing...

A Marketing Authorization Holder (MAH) is an entity—whether...

March 24, 2025
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