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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HSA Regulation of Topical Antiseptics in Singapore

HSA Regulation of Topical...

Antiseptics are essential tools in maintaining hygiene and...

March 21, 2025
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Regulation of Health Supplements in Singapore

Regulation of Health Supplements...

Health supplements play a significant role in supporting...

March 21, 2025
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FAQ – Singapore (HSA) Regulations for Medical Device Registration

FAQ – Singapore (HSA)...

Here are answers to some of the Frequently...

March 21, 2025
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HSA Medical Device Dealers Licenses in Singapore

HSA Medical Device Dealers...

The Health Sciences Authority (HSA) functions as the...

March 21, 2025
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Template for Literature Search and Screening for Clinical Evaluation of Medical Devices

Template for Literature Search...

The literature search and screening report for clinical...

March 21, 2025
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Pharmaceutical Regulations and Registration in Australia

Pharmaceutical Regulations and Registration...

The pharmaceutical market in Australia is projected to...

March 21, 2025
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Biologics and Biosimilars Regulations and Registration in Australia (TGA)

Biologics and Biosimilars Regulations...

The Australian healthcare system has transformed with the...

March 21, 2025
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Nutraceutical Regulation and Registration in Australia (TGA)

Nutraceutical Regulation and Registration...

In Australia, products categorized as 'complementary medicines' encompass...

March 21, 2025
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Australia (TGA) Medical Devices Regulations and Registration Process

Australia (TGA) Medical Devices...

Medical device is an instrument, apparatus or machine...

March 21, 2025
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