Overview

Although the electronic common technical document (eCTD) has been set as a standard format by a majority of Health Authorities (HAs), a paper copy of the dossier is still a legal requirement for the rest. Earlier, paper submissions were produced aligning with the paper-based CTD format. That necessitated the production of two (02) different submissions if an eCTD or Non-eCTD electronic Submissions (NeeS) were to be submitted. With two (02) different sets of submission formats, the execution and implementation demanded considerable additional efforts, affecting the companies’ costs. The only pragmatic solution to overcome this complexity was to allow applicants to use the eCTD or NeeS as the antecedent submission, following which the official paper submission is then printed. The printed copy primarily comprises a verified paper submission format. However, it is important to note that the paper submission is not intended to support dossier review as it has no paper-based navigation and review aids (for example, tables of content that reference paper volumes, tabs, etc.).

Freyr, with an expert Regulatory publishing and submissions team, caters value-added assistance for dossier submissions both in the paper as well as eCTD formats. With a strong foothold in the global Regulatory regime, Freyr decodes region-specific paper-based technicalities and paper submission formats to streamline paper submissions and offers comprehensive paper to eCTD conversions to support submissions to the HAs that accept the electronic format.