Registration and post-marketing assistance

Registration and post-marketing assistance

Once the bridging study is completed, the next step is to prepare a file for the regulatory authorities, in order to obtain a license for marketing the product in Europe. The submission can be done on various levels, mainly as a national procedure or a Mutual Recognition Procedure (MRP) where more countries are simultaneously implemented into the regulatory process and the approval is granted in more countries at the same time.

Accord Research offers an experienced post-marketing team who are able to compile the documentation, manage submission to the relevant authorities, and follow the regulatory process quickly and efficiently.

Accord Research has a relationship of long term cooperation and mutual communication with the Czech regulatory agency (SUKL and close cooperation between the Sponsor Company, Accord Research and SUKL will be maintained in order to proceed in the most efficient way during the process. Moreover, SUKL can also become a reference authority for further registration in Europe.
 

Accord Research does not have an in house sales and marketing team, but works in close collaboration with a professional provider who is able to work on any marketing activities required in the European region, emulating companies in the Asia Pacific region.  Accord Research is happy to make an introduction to this company should this be required.