Drug Master File (DMF)
AmpleLogic DMF Tracker allows you to manage the complete lifecycle of Applications filed against regulatory, starting from controlled correspondence to updating regulatory on the changes and events. DMF (Drug Master File) submissions can be managed until the closure with early alarms on commitment dates.
Our DMF tracker helps Regulatory Department or Quality Control (QC) Department of the Pharmaceutical and Biotech companies in tracking the applications and meeting the regulatory commitment dates with early Alarms
Drug Master File (DMF) contains data that is submitted to the 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 a 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 follows a similar kind of process Majority of the leading Pharmaceuticals and Biotech companies are currently using the Excel sheets to track the DMF submissions and customer communications as the data available in multiple systems. For keeping track of all the communications like Controlled correspondence, Queries, Amendments, Supplements, Deficiencies, Change Control details is quite challenging considering a 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.
Key Features of AmpleLogic DMF Tracking Solution
- 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.
- AmpleLogic DMF Tracker can allow 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.
- The detailed description of Change Controls against the products that include 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.
- DMF Tracker allows extracting the data from other systems namely change controls and Market Complaints about 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 of AmpleLogic Drug Master File (DMF) Tracker
- Single mouse click on the DMF application number will give the complete details of information, the communications, and the latest status.
- AmpleLogic DMF System will auto alerts on the Target dates and Due Dates, ensures timely responses to Regulatory and Customer Queries.
- Dashboards give the Complete Picture of the DMF Filings.
- Deficiencies, supplement details from other products help in filing reparation for similar kind of products