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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

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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Pharmacovigilance In Clinical Trials

Pharmacovigilance In Clinical Trials

Clinical trials are an integral part in the...

March 20, 2025
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NADFC Regulation of Nutraceuticals in Indonesia

NADFC Regulation of Nutraceuticals...

The nutraceutical market in Indonesia is expanding, with...

March 20, 2025
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Medical Devices Regulations & Registration In Indonesia

Medical Devices Regulations &...

Although the manufacturing sector for medical devices in...

March 20, 2025
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NADFC (BPOM) Regulations of Infant Formula in Indonesia

NADFC (BPOM) Regulations of...

Indonesia’s large population, coupled with a relatively high...

March 20, 2025
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EMA’s Clinical Trial Regulations (EUCTR) in European Union

EMA’s Clinical Trial Regulations...

The new EU Clinical Trial Regulation (CTR) 536/2014,...

March 20, 2025
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Understanding the Role of PRRC under EU MDR and IVDR

Understanding the Role of...

The advent of the EU Medical Device Regulations...

March 20, 2025
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Conformity Assessment of Medical Devices under EU MDR

Conformity Assessment of Medical...

The world of medical devices is a realm...

March 20, 2025
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Infant Formula Regulation and Follow-On Formula in European Union

Infant Formula Regulation and...

Infant nutrition is a critical aspect of early...

March 20, 2025
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Medical Device Risk Classification Under EU MDR

Medical Device Risk Classification...

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

March 19, 2025
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