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.
