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.
CONTACT US