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Jun 20, 20232 min read
ANVISA Updates Drug Registration Process in Brazil
The Brazilian health authority ANVISA (Agência Nacional de Vigilância Sanitária) has recently updated the drug registration process in Brazi
Jun 20, 20231 min read
What are the Responsibilities of an Indian Authorized Agent for Medical Devices Import?
An Indian Authorized Agent must fulfill critical responsibilities detailed in the Medical Device Rules (MDR), 2017 to be able to import
Jun 19, 20232 min read
Regulations for Registration of Medical Device in India (CDSCO)
Regulations for Registration of Medical Device in India is overseen by the Central Drugs Standard Control Organisation (CDSCO)
Jun 19, 20235 min read
Medical Devices Regulations in Hong Kong: Ensuring Safety and Quality
In Hong Kong, the Medical Device Control Office (MDCO) under the Department of Health oversees the regulations of medical devices.
Jun 12, 20233 min read
Medical Devices Registration Regulations by Singapore HSA
Singapore Medical Devices Registration as per Health Sciences Authority Regulations for four Class
Apr 17, 20231 min read
Malaysia's NPRA Has Issued A Report on Analysis of GMP Deficiencies
Malaysia's NPRA has released an analysis of the Deficiencies Found During On-Site Good Manufacturing Practises (GMP) Inspections of...
Apr 17, 20231 min read
Updated List of Approved Fixed-Dose Combinations (FDC) from CDSCO, India
After identifying "certain typographical" flaws in the original document, India's Central Drugs Standard Control Organisation (CDSCO)...
Jan 27, 20232 min read
Medical Devices Registration with Medical Device Authority (MDA) in Malaysia
Medical Devices in Malaysia re regulated by Malaysian Medical Device Authority (MDA). The Medical Devices need to be registered in Malaysia
Jan 23, 20232 min read
Indonesia - Regulations for Drug (Pharmaceutical) Registration
The National Agency of Drug and Food Control (BADAN POM) supervises drug and food control in Indonesia under the Health Law No. 36 of 2009.
Jan 21, 20232 min read
Marketed Pharmaceutical Products Lifecycle Management in Asia
Artixio’s Proven Experience in Managing Lifecycle for Marketed Products in Asia
Jan 21, 20233 min read
Generic Drug Registration Requirements in Taiwan
Taiwan’s pharmaceutical market was estimated $2.9 Billion in 2021 growing at the rate of 3% CAGR Taiwan’s market is dependent on imported...
Jan 10, 20233 min read
Regulatory Information Management Software
Demand for regulatory information management software is growing due to increasing compliance requirements from health authorities.
Jan 6, 20232 min read
Assessing the Regulatory Outsourcing Readiness
Exploring strategies and methods for assessing outsourcing readiness in pharmaceutical organizations.
Jan 4, 20233 min read
Pharma Artwork & Labeling Management Software
From content to carton, a pharmaceutical product's lifecycle includes scientific medical writing from product development (target product pr
Jan 4, 20234 min read
External Drivers for Regulatory Outsourcing
A Summary of scenarios that enable regulatory outsourcing requirements pharmaceutical and medical devices industry globally.
Jan 4, 20232 min read
Regulatory Outsourcing Scenarios
Regulatory departments within biopharma companies decide work with an external partner for one or more reasons, Need for specialized...
Jan 4, 20233 min read
Document Management Systems (DMS) for Pharmaceutical Industry
A 21 CFR Part 11 compliance DMS is part of overall compliance and quality requirements across pharmaceutical organizations.
Jun 30, 20220 min read
Jun 30, 20221 min read
Template for Literature Search and Screening for Clinical Evaluation of Medical Devices
The literature search and screening report for clinical evaluation of medical devices must be compiled covering following parameters.
Mar 1, 20227 min read
Pharmaceutical Regulations and Registration in Singapore
Drug Registration Process in Singapore per Regulations from Health Sciences Authority.
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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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