Overview

Non-eCTD electronic Submission (NeeS) format has been made mandatory in the European Union(EU) from 2003 onwards. When compared to the electronic common technical document (eCTD), NeeS is different in terms of navigating structures. It does not use the XML backbone. It also differs from eCTD with two relevant XML files, the index.xml and eu-regional.xml for the backbone of Modules 2 to 5 and Module 1 for the EU, respectively. As per country specific guidelines, using bookmarks and hyperlinks, the NeeS is based on granular PDF files, electronic tables of contents and electronic navigation.

With a clear-cut understanding and expertise in handling region-specific NeeS requirements, Freyr helps manufacturers navigate through Regulatory dossier compilation for publishing and submissions. Freyr specializes in creating NeeS submissions for:

  • Europe - Module 1 Specification, EU NeeS Validation Criteria
  • Australia/New Zealand - NeeS Validation Criteria
  • Gulf Corporation Council (GCC), Saudi Food and Drug Authority (SFDA) NeeS - Module 1 Specification and eCTD Validation Criteria
  • Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina – (ALMBiH) NeeS for all types of Regulatory submissions
  • Canada NeeS submissions for Clinical Trial Applications (CTAs)
 

Freyr Expertise

  • 21 CFR part 11 compliant
  • Pre-defined templates
  • Using appropriate template for sequence creation based on the submission request. Eg., for the Saudi, Europe or Rest of the World (ROW) Health Authorities (HA)
  • Audit-ready submissions
  • Document-level formatting as per respective HA guidelines
  • Multilevel quality check and review before sharing or dispatching the submission to client/HA
  • Dossier validation, and rectification of errors incurred during submission compilation
  • Document allocation and simplification 
 

Freyr Advantages

  • Flexible, easy-to-manage and secured environment
  • Template repository
  • Expertise on global NeeS requirements
  • Automated PDF renditioning and creation of required table of contents