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...
top of page
Search
- Apr 17
- 1 min
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
- 2 min
Malaysia - Medical Devices Regulations
Medical Devices in Malaysia re regulated by Malaysian Medical Device Authority (MDA). The Medical Devices need to be registered in Malaysia
- Jan 23
- 2 min
Indonesia - Drug (Pharmaceutical) Regulations
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
- 2 min
Marketed Pharmaceutical Products Lifecycle Management in Asia
Artixio’s Proven Experience in Managing Lifecycle for Marketed Products in Asia
- Jan 21
- 3 min
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
- 3 min
Regulatory Information Management Software
Demand for regulatory information management software is growing due to increasing compliance requirements from health authorities.
- Jan 6
- 2 min
Assessing the Regulatory Outsourcing Readiness
Exploring strategies and methods for assessing outsourcing readiness in pharmaceutical organizations.
- Jan 4
- 3 min
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
- 4 min
External Drivers for Regulatory Outsourcing
A Summary of scenarios that enable regulatory outsourcing requirements pharmaceutical and medical devices industry globally.
- Jan 4
- 2 min
Regulatory Outsourcing Scenarios
Regulatory departments within biopharma companies decide work with an external partner for one or more reasons, Need for specialized...
- Jan 4
- 3 min
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, 2022
- 0 min
- Jun 30, 2022
- 1 min
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, 2022
- 4 min
Drugs Registration in Singapore
Drug Registration Process in Singapore per Regulations from Health Sciences Authority.
- Feb 12, 2022
- 3 min
Registration of Pharmaceutical Products in China (NMPA)
National Medical Products Administration (NMPA)
Main regulatory body in China which handles pharmaceutical drug registration management
- Feb 7, 2022
- 2 min
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, 2022
- 1 min
Cosmetic Labeling Requirements - A Global Comparison
#cosmetic #labeling #usa #uae #mfds #southkorea #japan #singapore #india #australia #newzealand
- Jan 29, 2022
- 2 min
Regulatory Contract Staffing for a US Based Biotech Company
Artixio provides expert regulatory staff on contingent and contract basis to pharmaceutical and other lifesciences industries.
- Jan 29, 2022
- 2 min
Competitive Intelligence for a Global Anti-Depressant Drug Manufacturer
Artixio’s competitive intelligence experts are seasoned in developing comprehensive strategy across therapeutic areas, treatment modalities,
bottom of page