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

Pathway for Clinical Evaluation Medical Devices

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.

Feb 12, 20225 min read

Pharmaceutical Regulations in China

National Medical Products Administration (NMPA) Main regulatory body in China which handles pharmaceutical drug registration management

Feb 7, 20222 min read

Artwork Proofreading & Quality Check for Top-50 European Biopharma Clients

Artixio provides artwork and label proofreading & quality check services for pharmaceutical, OTC, consumer health, cosmetic & other products

Jan 31, 20221 min read

Cosmetic Labeling Requirements - A Global Comparison

#cosmetic #labeling #usa #uae #mfds #southkorea #japan #singapore #india #australia #newzealand

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Global, Concurrent, Experience Based

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