What Is Multi-Region Drug Registration?
Multi-Region Drug Registration refers to the process of getting approval from the regulatory body for the marketing of the medical drug in multiple locations.
What Is Lifecycle Regulatory Strategy?
The Lifecycle Regulatory Strategy refers to a systematic method of dealing with the regulatory obligations of a given pharmaceutical product as the regulatory needs arise over the product lifecycle.
What Is an Environmental Risk Assessment Report for Molecules?
The Environmental Risk Assessment Report for Molecules is a report which is prepared to assess if and how a certain kind of pharmaceutical molecule can affect the environment.
The Importance of Artwork Version Control in Achieving Medical Device Regulatory Compliance
Ensuring Accurate and Compliant Medical Device Artwork
Artwork version control plays a critical role in maintaining medical device regulatory compliance. Labels, packaging, instructions for use (IFUs), symbols, warnings, and product information must remain accurate, consistent, and aligned with approved regulatory requirements.
EDQM Regulatory Update PA/PH/CEP (14) 06, 2R: Guidance on Using an Intermediate CEP in a Final Substance CEP Application
The revised EDQM Regulatory Update PA/PH/CEP (14) 06, 2R guideline clarifies how a valid Certificate of Suitability (CEP) for an intermediate (CEP X) can support a CEP application for a final substance (CEP Y).