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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Competitive Intelligence for a Global Anti-Depressant Drug Manufacturer

Competitive Intelligence for a...

Artixio’s competitive intelligence experts are seasoned in developing...

April 1, 2025
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Case Study: Streamlined India Registration and Market Entry for Europe Gel-Based Nail Polish Brand

Case Study: Streamlined India...

Client: A prominent Europe-based Gel-Based Nail Polish brand...

April 1, 2025
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Medical Device Regulations and Registration in Canada (Health Canada)

Medical Device Regulations and...

In Canada, the medical devices are regulated by...

April 1, 2025
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New Drugs, Generics and Biosimilars Registration in Singapore: Whitepaper on HSA Regulations

New Drugs, Generics and...

Singapore stands as a beacon of regulatory excellence...

April 1, 2025
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Case Study: Market Access Support for an Oncology Drug with Agency for Care Effectiveness

Case Study: Market Access...

Artixio’s regional Market Access Team in Singapore helped...

April 1, 2025
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Case Study: Regulatory Compliance and Registration of AI algorithm with MoHAP, UAE

Case Study: Regulatory Compliance...

Entering a new market, especially one with a...

April 1, 2025
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Case Study: Product and Business Registrations for Cosmetic Products in the UAE

Case Study: Product and...

In an era of expanding global markets, navigating...

April 1, 2025
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Artixio Helps USA Pharma Company Register New Drugs on Time & on Budget Through Regulatory Staffing

Artixio Helps USA Pharma...

Regulatory affairs (RA) is a critical function for...

April 1, 2025
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A Case Study : Registration of Health Supplements in UAE

A Case Study :...

Navigating the complex regulatory landscape of a new...

April 1, 2025
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