Drug Master File (DMF Tracker)

AmpleLogic DMF Tracker manages the whole lifecycle of regulatory applications, from restricted correspondence to notifying regulatory authorities on changes and occurrences. Submissions of DMFs (Drug Master Files) may be tracked until they are closed, with prior warnings on commitment dates.

Our DMF tracker assists pharmaceutical and biotech companies’ regulatory departments and quality control (QC) departments in tracking applications and meeting regulatory commitment dates with early alarms provided by our DMF tracker.

The Scenario:

Data submitted to the FDA by the manufacturer for generic drug product approval is contained in the Drug Master File (DMF).

Upon receiving FDA clearance, pharmaceutical and biotech companies must disclose product modifications, respond to regulatory issues, and answer any additional inquiries relating to the ANDA Application Number that has been assigned.

Organizations are required to provide the Periodic Adverse Drug Experience Report (PADER) and eCTD data on a quarterly or annual basis, based on the aforementioned facts. Pharma and biotech companies must also interact with their consumers as well as with regulatory authorities.

As data is available on different platforms, the majority of the largest pharmaceutical and biotech businesses are now tracking DMF submissions and customer conversations using Excel sheets. Keeping track of all communications such as Controlled correspondence, Queries, Amendments, Supplements, Deficiencies, and Change Control information is difficult given the enormous number of applications.

It’s difficult to keep track of regulatory deadlines and obligations, and organizations frequently miss them, causing delays and deviations.

Features of AmpleLogic DMF Tracking Solution

  • All items would be managed by Product Master
  • Controlled Correspondence, Supplements, CR, Deficiency, Pader, and Notifications have their subtrackers
  • Tracking of Controlled Correspondence with RLD (Reference Listed Drug) Name, RLD Number, CC Filled and Sent by, Title of Inquiry and FDA Assigned Number, Dates of Response, and FDA Comments
  • It is possible to keep track of customer communications using AmpleLogic ANDA and DMF Tracker, as the date of the initial notice, customer inquiries, amendment submission dates, and the date of the final notification
  • Dates of customer queries, target dates, and completion dates are included in the report
  • The Deficiency Tracker provides the Deficiency Type, Deficiency Description, Action Items, Responsibility, and Deficiency Response/Closure Dates, as well as the underlying cause of each Deficiency found
  • Supplement Types, Supplements Against Deficiency, Supplement Grant Date, Supplement Request Date, FDA Response and Response Date, as well as RA remarks
  • The full description of Change Controls applied to goods, including current and planned changes, their rationale/justification, Change Classification RA & QA, and links to customer notifications, as well as information on implementation timelines, change completion, and effectiveness
  • PADER Tracker enables the entry of Periodic Adverse Drug Experience Report information, such as time, eCTD date, and submission date, in addition to the current date
  • It is possible to collect data from other systems, such as change controls and Market Complaints about Adverse events, using the Abbreviated New Drug Application (ANDA) Tracker
  • Users with job responsibilities have access restrictions. All sheets are accessible to regulatory users. However, only some sheets are accessible to QA

Benefits of AmpleLogic Drug Master File (DMF) Tracker

  • All the relevant information, including communications and the most recent status update, can be accessed through the DMF application number
  • To ensure prompt answers to regulatory and customer queries, the AmpleLogic System will send out automatic reminders on target and due dates
  • The DMF Filings are shown in full detail on the dashboards
  • Details about deficiencies and supplements from other products aid in the preparation of claims for compensation for related products

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