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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

AI Solutions For Pharma (From Regulatory Affairs to Custom Software)

AI Solutions For Pharma

As the technology is reaching its heights, new innovations like AI can...

September 1, 2025
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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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Quality System Regulations (QSR) under 21 CFR Part 820

Quality System Regulations (QSR)...

The Quality System Regulations (QSR), outlined in 21...

April 1, 2025
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eCTD Structure & Submission Process

eCTD Structure & Submission...

Common Technical Document (CTD) is a common standard...

April 1, 2025
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Case Study: Regulatory Contract Staffing for a US Based Biotech Company

Case Study: Regulatory Contract...

Artixio provides expert regulatory staff on contingent and...

April 1, 2025
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Case Study: Enabling Go/No-Go Decision for a Global Medical Devices Leader

Case Study: Enabling Go/No-Go...

Client: Client is a global medical devices leader...

April 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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