Glossary

Electronic Submissions Gateway (ESG)

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions [including eCTD]. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review.

The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach the proper FDA Center or Office.

Source: Electronic Submissions Gateway

Resources

Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.

Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.

Found 370 Results
Page 1 of 2































Arm

















































































































































ICH






























































































































Page 1 of 2