We are Azierta, experts in updating the file submission format.
European regulations have established a process to update the format for sending medication files to the Competent Authorities in order to manage the life cycle of the established traceability drug.
Azierta make it easier for our clients to adapt to the regulatory changes ICH eCTD through the following services:
Necessary support to carry out the consolidation of the dossiers, creating the necessary consolidation sequence for each client.
Generation of the eCTD
sequences and maintenance of the trees of the life cycles of the medicines in our archive.
Development of eCTD sequences from a NeeS sequence or from the separate documents for clients who do not have these softwares (simplification of the process and cost savings).