Quality System Regulations (QSR) under 21 CFR Part 820
The Quality System Regulations (QSR), outlined in 21 CFR Part 820, are critical guidelines established by the U.S. Food and […]
Biologics and Biosimilars Regulations and Registration in Brazil
According to the Drugs Sector Regulation Chamber (CMED) in 2022, the Brazilian pharmaceutical sector generated US $17.2 billion in sales
Case Study: 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 using both its in-house
Medical Device Risk Classification Under EU MDR
The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices in
What Is Structured Product Labeling (SPL)?
Structured Product Labeling format is used to submit the labeling content in electronic format. It is a standard document used
Phytopharmaceuticals Regulations & Registration In India
Phytopharmaceuticals are basically plant-based drugs, but developed in a more scientific way than the usual herbal products we see in
Class III Medical Devices: Meaning, Examples, Approval Process
FDA classifies medical devices into different categories based on their risk factor. Each class of medical device holds different rules and regulations as every one of you would
Types Of Medical Devices & Medical Device Classification System
As we know, the healthcare system and medical devices are co-dependent. The safety and effectiveness of medical devices matters when
Class II Medical Devices: Meaning, Requirements, Process
Running the healthcare system without the use of medical devices is nearly impossible. Medical devices have become an integral part