pharmaceutical regulatory science

The Journey of New Drug Discovery and Development: From Bench to Bedside Introduction:The process of discovering and developing…

The New Drug Application – A Comprehensive Guide to Regulatory Affairs Introduction:Every new drug that is introduced into…

Understanding the Role and Importance of Institutional Review Board in Regulatory Affairs Introduction:In the field of regulatory affairs,…

Investigational New Drug Application: A Crucial Step in Drug Development Introduction:In the realm of pharmaceutical research and development,…

The generic drug development process typically involves several stages, including pre-formulation studies, formulation development, stability studies, bioequivalence studies,…

An electronic common technical document (eCTD) is a standardized format for submitting regulatory information to regulatory agencies. It…

Genetic drug development is the process of using genetic information and technology to create new medicines that target…

A common technical document (CTD) in regulatory affairs is a comprehensive dossier that provides essential data and information…

An Abbreviated New Drug Application (ANDA) is a submission to the U.S. Food and Drug Administration (FDA) for…