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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.

Popular Articles

Articles On Pharmaceuticals

Drugs vs Medicines: Understand The Key Differences

Drugs vs Medicines: Understand

You all might always get confused the difference between drugs and medicine....

October 4, 2025
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Vietnam Pharmaceutical Regulations & Drug Registration Process

Vietnam Pharmaceutical Regulations &

Vietnam is the 7th fastest growing middle-class population in the world and...

October 26, 2025
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NADFC (BPOM) Pharmaceuticals Regulations In Indonesia

NADFC (BPOM) Pharmaceuticals Regulations

The pharmaceutical sector is expanding day by day to occupy solutions for...

November 1, 2025
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New Drug Application Meaning & Approval Process

New Drug Application Meaning...

NDA plays a very crucial role in the...

April 1, 2025
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Innovative Drug Delivery Systems

Innovative Drug Delivery Systems

While traditional oral pills remain a cornerstone of...

April 1, 2025
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Biologics & Biosimilar Regulations in European Union (EU) (EMA)

Biologics & Biosimilar Regulations...

In 2022, the Europe biosimilar market had a...

March 30, 2025
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What Is Certification Of Suitability (CEP) & Sister CEP Submissions?

What Is Certification Of...

All the regulatory documents or certifications are in...

March 28, 2025
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Individual Case Safety Report (ICSR)

Individual Case Safety Report...

The pharmacovigilance sector has a great role to...

March 28, 2025
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What Is Structured Product Labeling (SPL)?

What Is Structured Product...

Structured Product Labeling format is used to submit...

March 28, 2025
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503A vs 503B Compounding Pharmacies: Key Differences

503A vs 503B Compounding...

Compounding pharmacies aim to provide tailored medications according...

March 28, 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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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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