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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Pharmaceutical Manufacturing Facilities Registration in UAE (MOHAP)

Pharmaceutical Manufacturing Facilities Registration...

In the United Arab Emirates (UAE), the Ministry...

March 27, 2025
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Pharmacovigilance System Master File (PSMF)

Pharmacovigilance System Master File...

Pharmacovigilance (PV) is one of the most important...

March 26, 2025
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Class III Medical Devices: Meaning, Examples, Approval Process

Class III Medical Devices:...

FDA classifies medical devices into different categories based on their risk factor. Each class...

March 26, 2025
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Types Of Medical Devices & Medical Device Classification System

Types Of Medical Devices...

As we know, the healthcare system and medical...

March 26, 2025
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Class II Medical Devices: Meaning, Requirements, Process

Class II Medical Devices:...

Running the healthcare system without the use of...

March 26, 2025
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Class I Medical Device: Regulatory Classification

Class I Medical Device:...

In the US, Center For Devices And Radiological...

March 26, 2025
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Medical Devices Regulation With PFDA In Philippines

Medical Devices Regulation With...

In the Philippines, the medical device industry relies...

March 26, 2025
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Medical Devices Regulations in Hong Kong

Medical Devices Regulations in...

Hong Kong’s vibrant medical and healthcare equipment and...

March 26, 2025
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Hong Kong: New Drugs, Generics, Biosimilars Regulations

Hong Kong: New Drugs,...

Hong Kong- New Drugs, Generics, Biosimilar Regulations: Hong...

March 26, 2025
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