International registration
Prepare DMF
There are four types of Drug Master Files (DMFs) available now: Type II Drug Substance, Drug Substance Intermediate, a...
Prepare SMF
The site master file should contain specific information about the quality management policies and activities of the s...
Establishment Registration and Self-Identification
1.1 Setting up a WebTrader Account with the FDA Electronic Submissions Gateway (ESG)1. Request a WebTrader accountProv...
