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.

Popular Articles

Categories

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
Read More →
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
Read More →
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
Read More →
New Drug Application Meaning & Approval Process

New Drug Application Meaning...

NDA plays a very crucial role in the...

April 1, 2025
Read More →
Innovative Drug Delivery Systems

Innovative Drug Delivery Systems

While traditional oral pills remain a cornerstone of...

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

Biologics & Biosimilar Regulations...

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

March 30, 2025
Read More →
Computer System Validation (CSV) In Pharma

Computer System Validation (CSV)...

Computer systems are widely used in the pharmaceutical...

March 28, 2025
Read More →
What Is Certification Of Suitability (CEP) & Sister CEP Submissions?

What Is Certification Of...

All the regulatory documents or certifications are in...

March 28, 2025
Read More →
Individual Case Safety Report (ICSR)

Individual Case Safety Report...

The pharmacovigilance sector has a great role to...

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

What Is Structured Product...

Structured Product Labeling format is used to submit...

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

503A vs 503B Compounding...

Compounding pharmacies aim to provide tailored medications according...

March 28, 2025
Read More →
Pharmaceutical Manufacturing Facilities Registration in UAE (MOHAP)

Pharmaceutical Manufacturing Facilities Registration...

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

March 27, 2025
Read More →

All Articles