Overview

Although the electronic Common Technical Document (eCTD) has been set as a standard format by the majority of Health Authorities (HAs) globally, a paper copy of the dossier is still a legal requirement in some parts of the world. Earlier, paper submissions were aligned with the paper-based CTD format. That necessitated the production of two (02) different submissions, whether an eCTD or a non-eCTD electronic Submission (NeeS) was to be submitted. With two 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 was printed. However, it is important to note that paper submission is not intended to support dossier review as the latter has no paper-based navigation and review aids (for example, tables of content that reference paper volumes, tabs, etc.).

With an expert Regulatory publishing and submissions team, Freyr caters value-added assistance for dossier submissions both in the paper and eCTD formats. With a strong foothold in the global Regulatory regime, Freyr decodes region-specific paper-based technicalities to streamline submissions and offers comprehensive paper to eCTD conversion to support submissions to HAs that accept the electronic format.

 

Freyr Expertise

  • Navigation aid management of volumes with separators or tabs
  • Dispatching and delivering of paper submission as per Health Authority 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 the dynamic Regulatory guidelines
  • Point of contact for each 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