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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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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Digital Health In Regulatory Affairs

Digital Health In Regulatory...

The old traditional methods of diagnosis, treatment and...

April 7, 2025
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Pharmacovigilance of Vaccines in the USA (US FDA)

Pharmacovigilance of Vaccines in...

Pharmacovigilance is the science and activities related to...

April 5, 2025
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Local Representative for MDR in Mexico:Mexican Registration Holder (MRH) for COFEPRIS Communications

Local Representative for MDR...

In recent years, Mexico has emerged as a...

April 5, 2025
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US FDA Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

US FDA Modernization of...

The Modernization of Cosmetics Regulation Act (MoCRA), which...

April 5, 2025
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