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 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?
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.