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Jul 26, 20245 min read
Innovative Drug Delivery Systems
While traditional oral pills remain a cornerstone of drug delivery due to their simplicity and familiarity, innovative drug delivery...
Jul 10, 20244 min read
Hong Kong: New Drugs, Generics, Biosimilar Regulations
Hong Kong has a robust regulatory system for pharmaceuticals, overseen by the Department of Health (DoH).
Jan 19, 20246 min read
Medical Device, Diagnostics Regulations in Taiwan FDA - Frequently Asked Questions (FAQs)
The regulatory authority responsible for medical device registration in Taiwan is the Taiwan Food and Drug Administration (TFDA)
Jan 17, 20245 min read
Medical Device Regulations India - Frequently Asked Questions (FAQs)
Frequently asked questions (FAQs) regarding medical device registration and regulations in India
Dec 22, 20234 min read
Pharmaceutical Regulations and Registration in Malaysia
Malaysia's pharmaceutical market had demonstrated significant growth in recent years, reaching an impressive valuation of $2.9 billion in...
Dec 20, 20235 min read
Pharmaceutical Regulations in Thailand
The domestic pharmaceutical market in Thailand is anticipated to see a 4.5-5.0% growth in 2022 compared to the previous year. The easing...
Dec 5, 20234 min read
Nutraceutical Registration and Regulations in the UK (MHRA): A Comprehensive Guide
The global nutraceutical industry has experienced remarkable growth in recent years, largely due to a rising consumer focus on health and...
Nov 27, 20234 min read
Medical Device Regulations and Registration in Canada (Health Canada)
In Canada, the medical devices are regulated by Health Canada under Health Products and Food Branch, Therapeutic Products Directorate,...
Nov 25, 20233 min read
Medical Device Regulations in India (CDSCO)
India's healthcare sector is witnessing significant growth, with a burgeoning market for medical devices. The regulation of medical...
Nov 22, 20236 min read
Health Canada Cosmetic Regulations in Canada
Cosmetics play a vital role in our daily routines, but their safety and compliance with regulations are of utmost importance. The...
Nov 20, 20236 min read
Understanding Quality System Regulations (QSR) under 21 CFR Part 820
The Quality System Regulations (QSR), outlined in 21 CFR Part 820, are critical guidelines established by the U.S. Food and Drug...
Nov 10, 20235 min read
Taiwan Food and Drug Administration (TFDA) Drug Regulations in Taiwan
Taiwan, with its growing pharmaceutical market, is an attractive destination for drug manufacturers looking to introduce their products....
Nov 9, 20236 min read
CDSCO Regulation of Cosmetics in India
Cosmetics play a significant role in our daily lives, enhancing our beauty and self-esteem. In India, the cosmetics industry has...
Nov 8, 20234 min read
Taiwan Food and Drug Administration (TFDA) Medical Device Regulation in Taiwan
Taiwan is a growing market for medical devices, but gaining entry requires strict adherence to Taiwan medical device regulations set...
Nov 4, 20232 min read
Artixio’s Regulatory Support for a Chinese Pharmaceutical Manufacturer in Mexico
A case study outlining Artixio’s Regulatory Support for a Chinese
Pharmaceutical Manufacturer in Mexico.
Oct 29, 20235 min read
US FDA Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
The Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law on December 29, 2022, is a significant milestone in the...
Oct 27, 20234 min read
Regulation of Medical Devices with Philippines Food and Drug Administration (PFDA), Philippines
In the Philippines, the medical device industry relies heavily on imports for its products. Â Whether these products are made...
Oct 26, 20234 min read
Thailand FDA Regulations of Food manufactured or imported in Thailand
In Thailand, the oversight of food regulation primarily rests with various government agencies and departments tasked with ensuring food...
Oct 2, 20235 min read
Key Players in Medical Device Regulation: Economic Operators under EU MDR and IVDR
In the rapidly evolving landscape of medical device regulations, understanding the roles and responsibilities of economic operators is...
Sep 22, 20234 min read
Regulation of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations...
Insights
Global, Concurrent, Experience Based
Deep dive and engage in insightful discourse driven by concurrent global regulatory scenarios, industry trends and Artixio’s real-time experience across the product value chain. Whitepapers, research articles, landscape reports and case studies to help you stay ahead of the curve.
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