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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Regulations for Pharmaceutical Registration in Hong Kong

Regulations for Pharmaceutical Registration...

Pharmaceutical market in Hong Kong has reached a...

March 26, 2025
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Nutraceutical Regulations & Registration in Hong Kong (FEHD)

Nutraceutical Regulations & Registration...

Hong Kong stands out as a dynamic hub...

March 26, 2025
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Medical Device Registration in USA by US FDA

Medical Device Registration in...

The responsibility for overseeing the regulations of medical...

March 25, 2025
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510(k) Registration with US FDA – Medical Device Registration in USA

510(k) Registration with US...

Medical devices regulatory compliance is paramount to ensure...

March 25, 2025
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Digital (SEO) Strategies for a USA based Surgical Instruments Company

Digital (SEO) Strategies for...

Summary Boosting Surgical Company's digital presence, driving improved...

March 25, 2025
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Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)

Biologics and Biosimilars Regulations,...

The size of the U.S. biosimilars market, estimated...

March 25, 2025
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Pharmacovigilance of Biologics in the USA (US FDA)

Pharmacovigilance of Biologics in...

Pharmacovigilance plays a vital role in ensuring the...

March 25, 2025
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US FDA Pharmacovigilance Requirements For Drugs in the USA

US FDA Pharmacovigilance Requirements...

Pharmacovigilance is a cornerstone of drug regulation in...

March 25, 2025
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Q-Submission Meetings for Medical Devices with US FDA

Q-Submission Meetings for Medical...

The US Food and Drug Administration (US FDA)...

March 24, 2025
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