Overview

Although the electronic common technical document (eCTD) has been set as a standard format by majority of Health Authorities (HAs), a paper copy of 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 different submissions, if an eCTD or Non-eCTD electronic Submissions (NeeS) were to be submitted. With two different sets of submission formats, the execution and implementation demanded considerable additional efforts affecting companies cost. 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. However, it is important to note that 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 paper as well as eCTD formats. With a strong foothold in global Regulatory regime, Freyr decodes region-specific paper-based technicalities to streamline submissions, and also offers comprehensive paper to eCTD conversion to support submissions to HAs that accept electronic format.

 

Freyr Expertise

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

Freyr Advantages

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