US-FDA Drug Submission Procedures

Tougher regulatory approval processes pose potential set-backs for pharmaceutical companies registering drugs in the USA. Can you afford to waste your R and D investment by delaying your product launch? In the challenging environment of US drug registrations procedures, you and your colleagues need to understand all the current procedures. To help you do this, PTI has developed this course that will clarify the US regulatory process.

•Achieve faster drug registration in the US and be first to market to win market share
•Clarify the needs, expectations and regulatory requirements of the FDA for the drug registration dossier
•Prepare successful Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)