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Jan 25 min read
eCTD Structure & Submission Process
Common Technical Document (CTD) is a common standard format for submitting regulatory documents to the respective regulatory authorities...
Dec 27, 20246 min read
New Drug Application Meaning & Approval Process
NDA plays a very crucial role in the drug approval process. The regulation and control of new drugs in the United States has been based...
Dec 26, 20246 min read
What Is Investigational New Drug & Types Of IND
The governing federal law makes it a compulsion for the pharmaceuticals to be subject to the marketing application for their distribution...
Dec 9, 20245 min read
Gene Therapy Applications, Regulations & Guidance
The applications of gene therapy represent a revolutionary advancement in medicine, providing hope for curing diseases instead of relying...
Dec 3, 20243 min read
Phytopharmaceuticals Regulations & Registration Process In India
Phytopharmaceuticals are modern, plant-derived medicines developed through rigorous scientific processes, including extraction,...
Oct 29, 20246 min read
United Kingdom (UK) Cosmetic Regulations
The UK cosmetic industry is a dynamic and highly competitive market, known for its innovation, diversity, and robust regulatory...
Oct 28, 20245 min read
Cosmetics Regulation in Australia
The cosmetics industry is a vital part of Australia’s economy, offering a diverse array of products from makeup to skincare and personal...
Oct 22, 20244 min read
Real World Evidence (RWE) in Pharma Innovations
Real-World Evidence (RWE) refers to clinical evidence obtained from real-world data (RWD) on the use and potential benefits or risks of a...
Oct 21, 20244 min read
Pharmaceutical Patents Expiry: Generic Drug Development
As blockbuster drugs face patent expiries, pharmaceutical companies are adopting a range of strategies to navigate the resulting...
Oct 21, 20244 min read
Saudi FDA (SFDA) Regulation of Cosmetics in Saudi Arabia
The cosmetics market in Saudi Arabia has seen significant growth in recent years, driven by a combination of increasing consumer demand,...
Oct 19, 20245 min read
Impact of Drug Patent Expiry on Prices: Recent Trends
Patent expiry marks a significant milestone in the lifecycle of a pharmaceutical product. When a drug is first developed, the...
Oct 15, 20246 min read
Therapeutic Goods Administration TGA Regulation of Non-Prescription Medicine in Australia
In Australia, the regulatory agency responsible for non-prescription medicines is the Therapeutic Goods Administration (TGA). The TGA is...
Oct 13, 20243 min read
EMA Measures Towards Efficient Approval Process for New Medicines in European Union (EU)
Improving the efficiency of the approval process for new medicines within the European Medicines Agency (EMA) involves several strategies...
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...
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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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