Our client, a research-based pharmaceutical company, required support with the preparation of a written statement regarding the update and revision of the requirements directive (DMP-A-RL) for a disease management program (DMP) in Germany. The time frame was short, as including the correction and review process, a total of only 14 working days were available until finalization. The client was acutely affected by the DMP update with since he had several drugs on the market in the relevant indication.
We developed the complete statement on behalf of the client. The preparation of the statement included the processing of the entire guideline evidence and presentation of all relevant findings in the indication. Based on current evidence and taking into account the legitimate interests of the client, changes to the relevant sections of the requirements directive were proposed. All requirements of the client could be fully met within the tight timeframe.
The statement prepared by us could be submitted by the client in time. All changes requested by the client regarding the update and revision of the DMP-A-RL could be addressed in detail during the statement procedure. This made it possible to take into account all the points that were very important to the client in the further process of updating and revising the DMP-A-RL.
The client was highly satisfied with the result. In particular, the project management and the quality of the medical writing under enormous time pressure were appreciated.