Case Study: Global Regulatory Intelligence for Dental Brand
Client: A global dental care brand headquartered in the United States. Problem Statement: The Client had portfolio of dental care […]
Case Study: Enabling Product Positioning for Filtration Devices Using Primary Market Intelligence
Client Details: Client is a large scale, multi-industry conglomerate that markets filtration devices worldwide. Problem Statement: Client’s product leadership is
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 innovative Holographic 3D
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 Brazil. The
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