Japan has had a flurry of new drug regulations to ease their drug lag problem and make their country more conducive to innovative drugs. As mentioned last month, Japan's PMDA is now allowing the submission read more

There is more than one software involved in those tasks in my past small business experience. You will want to use templates and the embedded tools if possible to prepare the eCTD sections in Word. Accenture read more

Yes, you can reference their DMF. To do so you will need to request a Letter of Authorization from them to include in your submission (Module 1) that permits your company to reference their DMF. ------------------------------ read more

This message was posted by a user wishing to remain anonymous What is your response to a colleague (typically someone in Quality or Engineering) who says that it's a regulatory requirement therefore read more

This message was posted by a user wishing to remain anonymous any expert opinion on it?