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 made in line 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 would demand 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 printed. However, it is important to note that paper submission is not supportive for expedited dossier review as it lacks 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 and electronic publishing services, Freyr decodes region-specific paper-based technicalities to streamline submissions, and also offers comprehensive paper to eCTD conversions and transitions 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 conversions
  • Baseline submissions
 

Freyr Advantages

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