Abbreviated New Drug Application (ANDA)

AmpleLogic ANDA (Abbreviated New Drug Application) monitoring software enables you to handle the whole life cycle of applications submitted to regulatory authorities, from controlled correspondence to notifying regulatory authorities on modifications and occurrences. ANDA submissions can be managed until the deadline by setting up early warning systems for dates when commitments must be met.

Our Abbreviated New Drug Application (ANDA) tracker assists Pharma and Biotech organizations’ Regulatory Departments or Quality Control (QC) Departments in tracking applications and meeting regulatory commitment deadlines with early alarms.

The Scenario:

The Abbreviated New Drug Application (ANDA) and the Drug Master File (DMF) include information that is submitted to the US FDA for evaluation by the manufacturer to get possible authorization of a generic drug product.

Upon gaining 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 must 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 communicate with their consumers as well as regulatory agencies. As data is available on different platforms, the majority of the largest pharmaceutical and biotech companies are now tracking ANDA/DMF filings and customer interactions using Excel sheets. Keeping track of these queries and communication such as Controlled correspondence, Queries, Amendments, Supplements, Deficiencies, Change Control details is quite a tedious task considering their large volumes.

Also, it is difficult to monitor due dates of certain tasks and regulatory obligations, and this results in them missing out as a result of delays and deviations.

Features of AmpleLogic ANDA 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 ANDA Tracker

  • All the relevant information, including communications and the most recent status update, can be accessed through the ANDA 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 ANDA 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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