Focus: Chemistry, manufacturing and controls - Ensuring safe and effective pharmaceutical products
Members-only articles
Focus articles: Chemistry, manufacturing and controls
- Gene therapy products: regulatory challenges for industry
A regulatory view on the change management process for medicinal products
- Practical insights into the recent EU MDR framework
- Regulatory Framework for Platform Technologies
- CMC considerations for US biosimilars development
Other articles:
- Procedure withdrawals in Europe: past trends, impact and communication recommendations
- Amgen's experience of global expedited regulatory pathways in the development of sotorasib
Use the issue archive below to download the complete issue as a PDF or to access individual articles or complete issues going back to 2015.
Note: To access members-only content, you must be logged in to the site with your TOPRA Member account.