Paper Regulatory Submissions – 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, Regulatory submissions in paper format were produced aligning with the paper-based common technical document (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 company’s costs. The only pragmatic solution to overcome this complexity was to allow applicants to use the eCTD or NeeS as the antecedent submission, after which the official Regulatory submissions in paper format are printed. The printed copy primarily comprises a verified paper dossier submission format. However, it is important to note that the Regulatory Submissions in paper format 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 paper Regulatory submissions team, caters value-added assistance for dossier submissions in the paper and eCTD formats. With a strong foothold in the global Regulatory regime, Freyr decodes region-specific paper-based technicalities and Regulatory submissions in paper formats to streamline paper Regulatory submissions and offers comprehensive paper-to-eCTD conversions to support submissions to the HAs that accept the electronic format.