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
AI Solutions For Pharma
As the technology is reaching its heights, new innovations like AI can serve the pharmaceutical industry. Other side, pharma industry is under pressure from all...
IVD Medical Devices Registration
IVDs in India are regulated as drugs under Section 3(b)(i) and 3(b)(iv) of the Drugs and Cosmetics Act, 1940. With the drafting of Medical Devices...
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...
Health Supplements NPRA Regulations
In Malaysia, it’s not unusual to find health supplements being sold online without proper approval. The NPRA has even flagged cases where products made bold...
FSSAI Labeling Requirements For
Ensuring the safety and quality of infant formula is paramount for the health and development of infants. In India, the Food Safety and Standards Authority...
Food Supplement Regulations In
The increasing of health-conscious people has increased the demand of food supplements. Mexico has witnessed a steady growth of food supplement intake. According to the...
NADFC (BPOM) Regulations of
Cosmetics as per the regulations of NADFC/ BPOM, are preparations or substances that is used in the outer part of human body or the teeth...
NADFC (BPOM) Regulation Of
The pharmaceutical sector is expanding day by day to occupy solutions for new medical conditions that arise. With an increase in the unmet medical needs,...
FSSAI Alcoholic Beverages Regulations
India has been known for its rich heritage of alcoholic beverages and in recent years the manufacturing and sale of alcoholic beverages has increased tremendously....
Health Supplements Regulation and
The world we see today is more aligned with health. They tend to be more health conscious than ever. This is the reason for an...
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Articles On Pharmaceuticals
Pharmaceuticals Compliance, Regulations & Market Insights AI Solutions For Pharma
As the technology is reaching its heights, new innovations like AI can...
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Pharmaceuticals Compliance, Regulations & Market Insights Computer Software Assurance(CSA) In
Under 21 CFR part 11, it is required to validate the electronic...
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Pharmaceuticals Compliance, Regulations & Market Insights Pharma Manufacturing Booms in
Once overlooked pharma hub in Mexico's Hidalgo region has gained importance with...
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MedTech Medical Devices Regulations &...
Although the manufacturing sector for medical devices in...
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NADFC Compliance & Regulatory Guidance ArticlesNutraceuticals Compliance, Safety & Market Insights NADFC (BPOM) Regulations of...
Indonesia’s large population, coupled with a relatively high...
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EU EMA Regulatory Updates & Compliance Insights EMA’s Clinical Trial Regulations...
The new EU Clinical Trial Regulation (CTR) 536/2014,...
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EU EMA Regulatory Updates & Compliance InsightsMedTech Medical Device Risk Classification...
The European Union Medical Device Regulation (EU MDR)...
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EU EMA Regulatory Updates & Compliance Insights Role of Qualified Person...
In the intricate landscape of pharmaceutical regulation, ensuring...
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