Regulatory study Concept PDF
Regulatory study, also known as regulatory affairs, is a crucial aspect of drug development. Regulatory study involves a…
Regulatory Authority Body of Australia (TGA) PDF
A Comprehensive Guide to the Regulatory Authority Body of Australia Introduction:Australia’s pharmaceutical industry is one of the most…
New Drug Discovery and Development PDF
The Journey of New Drug Discovery and Development: From Bench to Bedside Introduction:The process of discovering and developing…
New Drug Application Regulatory Affairs PDF
The New Drug Application – A Comprehensive Guide to Regulatory Affairs Introduction:Every new drug that is introduced into…
Institutional Review Board in Regulatory Affairs PDF
Understanding the Role and Importance of Institutional Review Board in Regulatory Affairs Introduction:In the field of regulatory affairs,…
Investigational New Drug Application (IND) PDF
Investigational New Drug Application: A Crucial Step in Drug Development Introduction:In the realm of pharmaceutical research and development,…
generic drug development process
The generic drug development process typically involves several stages, including pre-formulation studies, formulation development, stability studies, bioequivalence studies,…
eCTD & ACTD complete notes PDF
An electronic common technical document (eCTD) is a standardized format for submitting regulatory information to regulatory agencies. It…
Concept Genetic drug development PDF
Genetic drug development is the process of using genetic information and technology to create new medicines that target…
common technical document (CTD) in regulatory affairs PDF
A common technical document (CTD) in regulatory affairs is a comprehensive dossier that provides essential data and information…