Competence boost Promimic AB

Important results from the project

The purpose of the project was to work through and develop a Master File that facilitates future registration projects for our customers. Customers should be able to refer directly to our Master File in their own registration process. The project achieved the target and Promimic has filed and registered a Master FiIe at the FDA, USA.

Expected long term effects

The result was a comprehensive Master File, which is reviewed and registered with the FDA. The expected impact is that our customers can easily refer directly to our Master File in their own product supbmissions. This will shorten the processing time for our customers and they will be able to reach the market earlier than planned by referring to our Master File.

Approach and implementation

The project was implemented according to the 4-step plan developed. 1) Identification of any shortcomings in existing material. 2) Establishment of regulatory strategy. 3) Use previous experiences and methods for similar work. 4) Final processing and compilation of Master File, in collaboration with US consultant, to submit to the FDA. Both the work with, both Swedish and American consultants worked well. Both sides contributed important experience and clear viewpoints to what requirements would be achieved and what the Master File would compile.