Category: Regulatory

What Is the European Medicines Agency? The European Medicines Agency, or EMA, handles the scientific review and safety checks for medicines used by people and animals across the European Union. It’s been around since 1995 and makes sure that any medicine you find in the EU is safe, actually works, and meets strict quality standards.

What Is a Development Safety Update Report (DSUR)? A Development Safety Update Report (DSUR) is a formal safety report that is prepared by the pharmaceutical companies at the clinical development stage of an investigational medicinal product (IMP). It is aimed at ensuring that participant safety is maintained by giving an overall annual review of all… Continue reading What Is a Development Safety Update Report (DSUR)?

What Is a Dossier Submission? Dossier Submission is a systematized procedure for gathering and submitting documentations to legal bodies to seek authorization of pharmaceuticals, medical devices, or healthcare items. Such dossiers show that a product has attained the necessary standards of quality, safety, and efficacy prior to becoming marketed or distributed in a particular country… Continue reading What Is a Dossier Submission?

What Is the Drug Information Association (DIA)? A worldwide nonprofit organization, the Drug Information Association (DIA) is committed to improving healthcare by fostering collaboration and knowledge sharing among experts in the creation, regulation, and lifecycle management of pharmaceuticals and medical products.

What is NextGen ESG? In the current dynamic regulatory and sustainability environment, NextGen ESG is a clear breakthrough in the way companies approach, report, and optimize their environmental, social, and governance (ESG) practices.

What Is Dossier Authoring? Dossier authoring means pulling together all the technical documents you need for regulatory submissions in pharma, biotech, or healthcare. You lay out everything—how the product’s made, how safe it is, how well it works, all the details regulators want to see before they sign off on a drug or medical product.

What is Drug Labeling? Drug labeling is the written, printed or graphic text that is placed with a pharmaceutical product either on the container, carton or package insert of the product. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and Cosmetic Act (FD&C Act) and FDA directions predetermine it.

What Is EU CTR Submission? EU CTR submission means sending in clinical trial applications under the rules set by the European Union Clinical Trials Regulation (EU CTR 536/2014). This regulation covers how clinical trials for medicines get approved, run, and overseen in EU countries.

What is Permitted Daily Exposure (PDE) Calculation At Masuu Global, patient safety is the central focus of pharmaceutical manufacturing and quality control. As companies increasingly use shared facilities to produce multiple products, the risk of cross-contamination becomes a major concern.

How to read a CEP – European Directorate for the Quality of Medicines(EDQM) Overview: Aim and scope of EDQM policy document PA/PH/CEP(15)31 “How to read a CEP” How to interpret the information laid down on CEPs