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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

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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CDSCO Regulation of New Cosmetics in India

CDSCO Regulation of New...

In an era of constant innovation, the cosmetics...

April 4, 2025
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CDSCO Manufacturing License for Cosmetics in India

CDSCO Manufacturing License for...

In India, the cosmetic industry is burgeoning, with...

April 4, 2025
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Registration of Biologics in Malaysia (NPRA)

Registration of Biologics in...

Biologics have emerged as a significant treatment for...

April 4, 2025
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Biologics and Biosimilar Regulation and Registration in Japan (PMDA)

Biologics and Biosimilar Regulation...

With the exception of the United States, Japan's...

April 4, 2025
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Regulations of Reusable Medical Devices under EU MDR

Regulations of Reusable Medical...

The introduction of the EU Medical Device Regulation...

April 4, 2025
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CDSCO Registration of Multiple Product Variations of Cosmetics in India

CDSCO Registration of Multiple...

The cosmetic industry thrives on innovation and diversity,...

April 3, 2025
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System and Procedure Packs in Accordance with EU MDR

System and Procedure Packs...

In today's healthcare system, the role of system...

April 3, 2025
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DIGIPRIS: Mexico COFEPRIS Digital Platform for Product Registrations and Regulatory Submissions

DIGIPRIS: Mexico COFEPRIS Digital...

DIGIPRIS system (Sistema Digital de Procesos y Servicios...

April 3, 2025
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Post-Market Surveillance In Medical Device Regulation

Post-Market Surveillance In Medical...

One of the biggest accomplishments in the journey...

April 3, 2025
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