Overview

The 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), the non-eCTD electronic submission or NeeS is different in terms of navigating structures. It does not use the XML backbone. It also differs from eCTD with two (02) relevant XML files, the index.xml and the eu-regional.xml for the backbone of Modules 2 to 5, and Module 1 for the EU, respectively. As per the country-specific guidelines, 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 requirements for NeeS submissions, Freyr helps manufacturers navigate through the 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

  • 21CFR part 11 compliant
  • Pre-defined templates
  • Using the appropriate template for sequence creation based on the submission request, e.g., for SFDA, EU, or the Rest of the World (ROW) Health Authorities (HA)
  • Audit-ready submissions
  • Document-level formatting as per the respective HA guidelines
  • Multilevel quality checks 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 in global NeeS requirements and NeeS submissions
  • Automated PDF renditioning and creation of the required table of contents
 

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