ANDA and DMF Tracker

ANDA and DMF Applications Tracking Solution

The ANDA and DMF tracker of AmpleLogic allows you to manage the complete Lifecycle of Applications filed against regulatory, starting from controlled correspondence to updating regulatory on the changes and events. ANDA and DMF submissions can be managed till the closure with early alarms on commitment dates.

Our ANDA and DMF Tracker helps Regulatory Department/ Quality Control (QC) Department of the Pharma and Biotech companies in tracking the applications and meeting the regulatory commitment dates with early Alarms.

The Scenario:

Abbreviated new drug application (ANDA) and Drug Master File (DMF) contains data that is submitted to US FDA for the review by the manufacturer to get the potential approval of a generic drug product.

After receiving the receipt of approval from the US FDA, the Pharmaceutical and Biotech companies need to communicate for the product changes, provide response to deficiencies and other queries to regulatory against the assigned ANDA Application Number.

Mentioning the above information, organizations need to submit the Periodic Adverse Drug Experience Report (PADER) along with eCTD details on quarterly or annually basis.

Along with the communications to Regulatory the Pharma/Biotech industries also need to communicate the same to customers.

The DMF, Drug master files follow the similar kind of process.
Majority of the leading Pharmaceuticals and Biotech companies are currently using the Excel sheets to track the ANDA/DMF submissions and customer communications as the data availability in multiple systems. For keeping track of all the communications like Controlled correspondence, Queries, Amendments, Supplements, Deficiencies, Change Control details is quite challenging considering the large number of applications.

Keeping track of Goal dates and the commitments given to regulatory is quite challenging and sometimes the organizations miss their due dates results in delays and deviations.

Our Solutions:

The Key features include

  • Product Master to manage all the products
  • Separate sub trackers for entering Controlled Correspondence, Supplements, CR, Deficiency, Pader, Notifications.
  • Controlled Correspondence Tracking with RLD (Reference Listed Drug) Name, RLD Number, CC Filled and Sent by, Title of inquiry along with FDA Assigned Number, Responded dates along with FDA comments.
  • Allows to record and track customer notifications Like Initial Notification Date, Customer Inquiries, Amendments Submission date and Final Notification.
  • Customer Queries along with Query receipt date, Target date and Completion date.
  • Deficiency Tracker includes the Deficiency Type, Deficiency Description, Action Items, Responsibility and Deficiency Response/Closure Dates along with the root cause.
  • Supplement Types, Supplement against Deficiency, Supplement Grant Date, Request Date, FDA Response and the Date of Response along with RA comments.
  • Detailed description of Change Controls against the products that includes Existing and proposed change, Reason/Justification, Change Classification RA & QA, Link with customer notifications along with Implementation Timelines, Completion of change and effectiveness details.
  • PADER Tracker allows Periodic Adverse Drug Experience Report submission details along with time period, eCTD date and Submission Date.
  • ANDA and DMF Tracker allows to extract the data from other systems namely change controls and Market Complaints for 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.

Benefits:

  • Single mouse click on the ANDA/DMF application number will give the complete details of information, the communications and the latest status.
  • Auto Alerts on the Target dates and Due Dates, ensures timely responses to Regulatory and Customer Queries.
  • Dashboards gives the Complete Picture of the ANDA and DMF Filings.
  • Deficiencies, supplement details from other products helps in filing reparation for similar kind of products.