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Jun 17, 20244 min read
FSSAI Regulation of Alcoholic Beverages in India
FSSAI Regulation of Alcoholic Beverages in India
May 6, 20243 min read
Managing CDSCO registration of Multiple Product Variations of Cosmetics in India
The cosmetic industry thrives on innovation and diversity, offering consumers a wide array of products to meet their varied preferences....
Apr 22, 20242 min read
New Drugs, Generics and Biosimilar Registration in Singapore: Whitepaper on HSA Regulations
Guide to regulation in Singapore, insights into regulatory authorities, registration processes, & compliance for Drugs & Biosimilar
Mar 22, 20244 min read
COFEPRIS Makes Changes to Revamp Medical Device Regulations
In a significant regulatory update, Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has introduced new...
Mar 7, 20242 min read
Case Study: ASEAN Regulatory & Market Access Strategy for Japanese Pharmaceutical Manufacturer
Artixio, a leading consulting provider in the regulatory and commercial landscape, assisted a Japanese pharmaceutical company in...
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
Jan 9, 20242 min read
Case Study: Successful Registration of Software as Medical Device (SaMD)assisting Surgical procedure
Client: The client, a pioneering European company specializing in advanced medical technologies, sought regulatory approval for its...
Jan 1, 20245 min read
US FDA Guidance on Registration and Listing of Cosmetic Products and Facilities under Modernization of Cosmetics Regulation Act (MoCRA)
In December 2023, the United States Food and Drug Administration (FDA) ushered in a new era for the cosmetics industry with the release...
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 18, 20234 min read
Pharmaceutical Registration Process in Mexico (COFEPRIS)
Mexico is a major market in LATAM region. Pharmaceutical importation is expected to grow to $4.4 bn by 2024 ata CAGR of 2.2%. The...
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...
Dec 2, 20233 min read
Demystifying the Role of Indian Authorized Agents in Medical Device Registration
In the intricate landscape of medical device regulations in India, the role of the Indian Authorized Agent (IAA) stands as a pivotal link...
Nov 5, 20232 min read
Cosmetics Labeling for COFEPRIS compliance in Mexico
NOM-141-SSA/SCFI-2012 is a Mexican standard that establishes labeling requirements for prepackaged cosmetic products. This standard...
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.
Nov 3, 20233 min read
Notice of Operation : Essential Pre-requisite for registration of products with COFEPRIS, Mexico
A Notice of Operation in Mexico, or Aviso de Funcionamiento en México, is a document that must be filed with the Mexican Ministry of...
Nov 2, 20234 min read
Medical Device Registration Pathways in Mexico : Standard and Expedited Review Routes
Mexico is a growing market for medical devices, and medical device manufacturers are increasingly looking to register their products in...
Oct 21, 20233 min read
Local Representative for MDR in Mexico:Mexican Registration Holder (MRH) for COFEPRIS Communications
In recent years, Mexico has emerged as a highly attractive destination for businesses looking to expand their operations, particularly in...
Oct 19, 20234 min read
Medical Device Regulations in India : A Closer Look at CDSCO Application Forms
The Central Drugs Standard Control Organization (CDSCO) in India plays a pivotal role in regulating the manufacture, sale, and...
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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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