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?
Author: masuuglobal
What Is the Drug Information Association (DIA)?
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 Drug Safety?
What Is Drug Safety? Drug safety or pharmacovigilance is the field and practice of identifying, evaluating, interpreting, and averting the negative effects or any other issues regarding drugs. Its main aim is to guarantee that drugs are safe in the lifecycle of their patient use that is, both in clinical development and in post-marketing use.
What is NextGen ESG
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?
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 Audit Readiness?
What Is Audit Readiness? Audit readiness in the pharmaceutical industry refers to a company’s continual state of preparedness for regulatory, internal, and external audits related to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and other quality and compliance standards.
What is Drug Labeling?
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?
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
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)
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