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.

 

Freyr Expertise

  • Navigation and management of volumes with separators or tabs
  • Dispatching and delivering paper submissions as per the HA specifications for paper publishing
  • Paper to eCTD conversion/transition
  • Baseline submissions
 

Freyr Advantages

  • Proven expertise in dispatching large volumes of submissions
  • Well-versed Regulatory team keeping track of the ever-changing Regulatory guidelines
  • Point of contact for each paper submission
  • Dedicated QC teams
  • Quick submission turnaround times (includes single-day submissions)
 

Freyr SUBMIT PRO

For faster, compliant and seamless submissions, Freyr offers an in-house eCTD tool Freyr SUBMIT PRO. Freyr SUBMIT PRO suits all your submission requirements across the globe and supports regional formats. To know more about Freyr SUBMIT PRO, gain a comprehensive overview at:

www.ectdtool.com