Paper Regulatory Submissions - Overview
Although the electronic common technical document (eCTD) has been set as a standard format by most 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 submission 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.
Paper Regulatory Submissions
- Navigation and management of volumes with separators or tabs
- Dispatching and delivering paper submissions of Regulatory information as per the HA specifications for paper publishing
- Paper to eCTD conversion/transition
- Baseline paper submissions of Regulatory information
- Proven expertise in dispatching large volumes of Regulatory submissions in paper format
- Well-versed Regulatory team keeping track of the ever-changing Regulatory guidelines
- Point of contact for each paper submissions of Regulatory information
- Dedicated QC teams.
- Quick submission turnaround times (includes single-day submissions)
