Drug Master File (DMF) Review

The DMF constitutes a vital part of any application that requires close control on the quality of the DS manufactured. In first instance the DMF can only be submitted linked with an application for marketing authorisation of a medicinal product. Following are the services provided:

• Review and assessment of the contents of the DMF to ensure compliance with current requirements.
• Work closely with the applicant and DMF holder to provide response to the points of concern raised during the assessment of the application.
• Providing direct advise to the DMF holder concerning the restricted part of the DMF during the progress of the application
• Management and follow up of post approval commitment made by DMF holder linked to the quality of the medicinal product.