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 →
Case Study: Global Regulatory Intelligence for Dental Brand

Case Study: Global Regulatory...

Client: A global dental care brand headquartered in...

April 1, 2025
Read More →
Artixio’s Regulatory Support for a Chinese Pharmaceutical Manufacturer in Mexico

Artixio’s Regulatory Support for...

A case study outlining Artixio’s Regulatory Support for...

April 1, 2025
Read More →
Case Study: Enabling Product Positioning for Filtration Devices Using Primary Market Intelligence

Case Study: Enabling Product...

Client Details: Client is a large scale, multi-industry...

April 1, 2025
Read More →
Case Study: Successful Registration of Software as Medical Device (SaMD) Assisting Surgical Procedure

Case Study: Successful Registration...

Client: The client, a pioneering European company specializing...

April 1, 2025
Read More →
Pharmaceutical Packaging Graphic Design – Challenges and Remediation

Pharmaceutical Packaging Graphic Design...

Pharmaceutical companies face several key challenges when it...

April 1, 2025
Read More →
Quality System Regulations (QSR) under 21 CFR Part 820

Quality System Regulations (QSR)...

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

April 1, 2025
Read More →
eCTD Structure & Submission Process

eCTD Structure & Submission...

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

April 1, 2025
Read More →
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
Read More →
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
Read More →

All Articles