Drug Master File (DMF) is a set of well structured document prepared by a pharmaceutical drug manufacturer. The manufacturer submits, solely at his discretion to the appropriate regulatory agency / authority in the intended drug market.

In the United States, a DMF is submitted to the Food and Drug Administration (FDA) Agency. There is no requirement by law or FDA regulation to present a DMF. The document may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
SoluSoft Document Management and Workflow solutions are capable to manage the DMF submissions to various regulatory agencies and customers with proper versioning and folder structure. The final version of the DMF can then be packed as cut into a Compact Disk for submission. Below is a list of DMF features supported by SoluSoft solutions.

DMF Management Features

• Store and archive electronic copy of all DMF (US / Europe / CEP / Canada / Japan / China / Korea etc) sequentially in a well formatted folder structure based on DMF template.
• Store and archive electronic copy of all Annual Updates and Amendments / Query response to DMF submitted to Authority and its direct linkage to original submission
• Store and archive electronic copy of all Applicant DMF given to customers with their version number and their correlation with DMF filed in regulatory agency with history
• Store and archive data along-with search engine for query responses given to customers
• Store and archive list of all LOA given for referring DMF different for US  / EU / CEP
• Store and archive following Declarations given to Authorities / Customers.

• Residual Solvent Declaration
• Mesityl Declaration
• GMO Declaration
• LOE
• Absence or control of Metallic impurity

Custom Reports

• Electronic Listing of all regulatory submissions and all customer data submission
• Queries reported to Authority product wise and responded to customers

Search

• Search on DMF number, DMF version, Customer, Regulatory agency or document based on folder structure.
• Custom search