Marketing authorisation dossiers and maintenance

DADA has produced over 500 complete state-of-the-art marketing authorisation files for medicinal products that have been successfully registered throughout Europe. For many of these marketing authorisations DADA also performs dossier maintenance throughout the life-cycle, resulting in an on-going series of variation and renewal applications that are submitted to the competent authorities.
Naturally our dossiers conform to the current EU or US requirements of the electronic common technical dossier eCTD, and we can convert your dossier to this format as well. Dossiers can also be provided in the locally accepted non-eCTD electronic submission formats, if required.