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
Global Medical Device Statistics,
There are an estimated 2 million different kinds of medical devices on the world market, grouped into more than 7,000 generic device groups,...
Global Pharmaceutical Statistics, Facts
Global pharmaceutical market is estimated at $1.837 trillion in 2026 — but no medicine reaches that market instantly. It advances through research, preclinical development, clinical...
Pharmaceutical Drug Patent Expiry:
A pharma product’s lifecycle will reach a significant milestone in the form of patent expiry. In an initial drug development phase, the manufacturer may be...
New Drug Application Meaning
Drug companies cannot market a new medicine in the United States without FDA authorization. That authorization is requested through a NDA, full form of which...
IND Vs NDA In
Bringing a new drug to market in the U.S. isn’t a straight shot. Before a company can even think about selling it, the FDA wants...
What Is CDSCO SUGAM
The word SUGAM means “easy to approach” in Sanskrit. Just like how it means it was developed by CDSCO to streamline the regulatory process and...
Drugs vs Medicines: Understand
What we casually call medicine may technically contain one or more drugs. A drug can be used in different ways, while medicine is generally associated...
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Articles On Pharmaceuticals
Pharmaceuticals Insights Drugs vs Medicines: Understand
What we casually call medicine may technically contain one or more drugs....
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Pharmaceuticals Insights Vietnam Pharmaceutical Regulations &
Vietnam is the 7th fastest growing middle-class population in the world and...
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NADFC Compliance BPOM Pharmaceutical Regulations in
BPOM (Badan Pengawas Obat dan Makanan), also known as the National Agency...
Read More →Articles On Medical Devices
Pharmaceuticals Insights Drugs vs Medicines: Understand
What we casually call medicine may technically contain one or more drugs....
Read More → Pharmaceuticals Insights Vietnam Pharmaceutical Regulations &
Vietnam is the 7th fastest growing middle-class population in the world and...
Read More → NADFC Compliance BPOM Pharmaceutical Regulations in
BPOM (Badan Pengawas Obat dan Makanan), also known as the National Agency...
Read More →
All Articles
Case Study Case Study: Enabling Product...
Client Details: Client is a large scale, multi-industry...
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Case Study Case Study: Successful Registration...
Client: The client, a pioneering European company specializing...
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ANVISA ComplianceRegulatory Updates ANVISA Updates Drug Registration...
The Brazilian health authority ANVISA (Agência Nacional de...
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Pharmaceuticals Insights Quality System Regulations (QSR)...
The Quality System Regulations (QSR), outlined in 21...
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ANVISA ComplianceBiologics Biologics and Biosimilars Regulations...
According to the Drugs Sector Regulation Chamber (CMED)...
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Case Study Case Study: Regulatory Contract...
Artixio provides expert regulatory staff on contingent and...
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Pharmaceuticals Insights Innovative Drug Delivery Systems
While traditional oral pills remain a cornerstone of...
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EU EMA ComplianceMedTech Insights Medical Device Risk Classification...
The European Union Medical Device Regulation (EU MDR)...
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