Registration dossier documents
Completion of the dossier in accordance with the requirements of the EAEU, preparation of SmPC and PIL, compilation of reviews and summaries of preclinical and subsequent studies, quality reviews, amendments to the dossier on the EAEU.
We have accumulated practical experience in passing the examination of registration documents for the EAEU.
We have accumulated practical experience in passing the examination of registration documents for the EAEU.
Leading experts will prepare the missing CTD modules, draw up the SmPC and PIL in accordance with the current requirements of the regulatory authority.