Artixio’s Regulatory Support for a Chinese Pharmaceutical Manufacturer in Mexico
A case study outlining Artixio’s Regulatory Support for a Chinese Client: Pharmaceutical Manufacturer in Mexico. Problem Statement A Chinese Pharmaceutical […]
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
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
Case Study: Enabling Go/No-Go Decision for a Global Medical Devices Leader
Client: Client is a global medical devices leader with strong presence in syringes market. Problem Statement: The Company’s R&D department
Biologics & Biosimilar Regulations in European Union (EU) (EMA)
In 2022, the Europe biosimilar market had a value of almost USD 4601.56 million. In addition, it is anticipated that
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
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