ANDA Tracker

ANDA – Abbreviated New Drug Application Tracking Solution

ANDA – Abbreviated New Drug Application Tracking Solution

ANDA (Abbreviated New Drug Application) tracking solution allows you to manage the complete life cycle of applications filed against regulatory, starting from controlled correspondence to updating regulatory on the changes and events.

Benefits of ANDA Tracker

Communications

Single mouse click on the ANDA application number will give the complete details of information, the communications, and the latest status.

Auto alerts

System will auto alerts on the Target dates and Due Dates, ensures timely responses to Regulatory.

Easily integrates

Dashboards give the Complete Picture of the ANDA Filings.

Features of ANDA Tracking Solution
--> Product Master to manage all the products.

--> Separate sub trackers for entering Controlled Correspondence, Supplements, CR, Deficiency, Pader, Notifications.

--> Abbreviated New Drug Application (ANDA) Tracker allows extracting the data from other systems namely change controls and Market Complaints about Adverse events.

--> Restricted access to users based on their Job responsibility. Regulatory users can access all the sheets but the QA can access specific sheets.