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Oct 10, 20244 min read
BPOM (NADFC) Regulation on Contamination Limits in Cosmetics
Contamination of toxins in cosmetics is a significant public health concern. Harmful substances can inadvertently or deliberately enter...
Oct 10, 20246 min read
NADFC (BPOM) Regulations of Infant Formula in Indonesia
Indonesia’s large population, coupled with a relatively high birth rate, continues to fuel demand for infant food products. The growing...
Oct 5, 20246 min read
EMA's Clinical Trial Regulations (EUCTR) in European Union
The new EU Clinical Trial Regulation (CTR) 536/2014, which came into effect on January 31, 2022, represents a significant overhaul of the...
Oct 3, 20242 min read
Importing Medical Devices in Thailand: Process and Regulations
Thailand, with its rapidly advancing medical sector, offers a promising market for medical device importers
Oct 1, 20246 min read
Taiwan FDA (TFDA) Regulation of Cosmetics in Taiwan
The cosmetics industry is a vital sector in Taiwan, with an increasing emphasis on safety and quality. The Taiwan Food and Drug...
Sep 29, 20245 min read
Taiwan FDA (TFDA) Cosmetic Product Information File
When it comes to launching cosmetic products in Taiwan, navigating the regulatory landscape is crucial. The Taiwan Food and Drug...
Sep 28, 20247 min read
NADFC (BPOM) Regulation of Pharmaceuticals in Indonesia
The pharmaceutical market in Indonesia is one of the largest in Southeast Asia, driven by a combination of factors such as a large...
Sep 28, 20246 min read
NADFC (BPOM) Regulations of Cosmetics in Indonesia
The cosmetic industry in Indonesia is one of the fastest-growing sectors, driven by a large population, rising income levels, and...
Sep 27, 20242 min read
Navigating the Regulations for Import of Medical Devices into India
In the realm of medical device manufacturing, navigating the regulatory landscape can often feel akin to exploring a maze where each turn...
Sep 22, 20244 min read
Bioconjugates: Combining the Best of Biologics and Small Molecules
Bioconjugates are molecules formed by chemically linking two or more molecules, typically involving a biological molecule like a...
Sep 22, 20247 min read
NADFC Regulation of Nutraceuticals in Indonesia
The nutraceutical market in Indonesia is expanding, with projections indicating significant growth over the next few years. This growth...
Sep 6, 20243 min read
What Is a Marketing Authorization Holder (MAH)?
Marketing Authorization Holder is an entitythat holds the regulatory approval to distribute, sell, and commercialize pharmaceutical products
Sep 6, 20242 min read
Artixio Recognizes Femicura Healthtech as GEMi Grant Winner for Innovative Medtech Solutions
Artixio proudly announces Femicura Healthtech as the recipient of the prestigious GEMi (Grant for Early-Stage Medtech Innovations)
Sep 2, 20246 min read
COFEPRIS Regulation of Nitrosamines in Pharmaceuticals in Mexico
COFEPRIS Regulation of Nitrosamines in Pharmaceuticals in Mexico
Aug 30, 20244 min read
Pharmacovigilance of Vaccines in the USA (US FDA)
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or...
Aug 30, 20244 min read
Pharmacovigilance of Biologics in the USA (US FDA)
Pharmacovigilance plays a vital role in ensuring the safety and efficacy of biologics, which are complex therapeutic agents derived from...
Aug 29, 20245 min read
The Use of Virtual Reality (VR) and Augmented Reality (AR) in Pharma Training and Education
As the technology continues to evolve, the use of Virtual Reality (VR) and Augmented Reality (AR) in Pharma Training and Education is...
Aug 29, 20243 min read
Regulatory Challenges in Bringing Generic Drugs to the Market Post-Patent Expiry
Generic drugs are medications that are created to be equivalent to brand-name drugs in terms of dosage form, safety, strength, route of...
Aug 23, 20243 min read
Patent Expiry Alert: Blockbuster Drugs Expected to Lose Protection in the Next Five Years
Patent expiry refers to the end of the legal protection period granted to a patented invention or product. When a pharmaceutical company...
Aug 21, 20244 min read
Biosimilars: Affordable and Effective Alternatives to Biologics
Biosimilars are biologic medical products that are highly similar to an already approved reference biologic drug. They are designed to...
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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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