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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Biosimilars: Affordable and Effective Alternatives to Biologics

Biosimilars: Affordable and Effective...

Biosimilars are biologic medical products that are highly...

April 2, 2025
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Meeting EU Regulations: Role of the European Authorized Representative (EAR)

Meeting EU Regulations: Role...

When foreign medical device and IVD manufacturers seek...

April 2, 2025
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Case Study: Nitrosamine Impurities Analysis – Artixio’s Strategic Staffing Solutions for a Generic Drug Manufacturer based in the USA

Case Study: Nitrosamine Impurities...

Artixio stands out in the regulatory staffing industry...

April 2, 2025
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EU MDR Labelling Requirements For Medical Devices

EU MDR Labelling Requirements...

The European Union Medical Device Regulation (EU MDR)...

April 2, 2025
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Case Study : Mexico Market Research Report for Generic Aerosols Manufacturer

Case Study : Mexico...

Client Background: A leading African company specializing in...

April 1, 2025
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Case Study : Ensuring COFEPRIS Regulatory Compliance for Health Supplements in Mexico

Case Study : Ensuring...

Client Background: The client, an US based health...

April 1, 2025
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Regulatory Contract Staffing in Mexico for a Leading Medical Device Manufacturer

Regulatory Contract Staffing in...

Artixio, a trusted player in the regulatory and...

April 1, 2025
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Artwork Proofreading & Quality Check for Top-50 European Biopharma Clients

Artwork Proofreading & Quality...

Artixio is helping pharmaceutical companies with their artwork...

April 1, 2025
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Pharmaceutical Drug Patent Expiry: Price Impact, Regulatory Challenges & More..

Pharmaceutical Drug Patent Expiry:...

Patent expiry marks a significant milestone in the...

April 1, 2025
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