Non-eCTD Electronic Submissions (NeeS)

Freyr specializes in NeeS Regulatory submissions, offering expertise in dossier compilation, publishing, and submissions for various regions, ensuring compliance with country-specific guidelines and validation criteria.

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Non-eCTD Electronic Submissions (NeeS) - 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 Non-eCTD Electronic Submission (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 NeeS Format dossier compilation for publishing and submissions. Freyr specializes in creating NeeS Regulatory 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 submissions for all types of Regulatory submissions
  • Canada NeeS submissions for Clinical Trial Applications (CTAs)

Non-eCTD Electronic Submissions (NeeS)

  • 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 Non-eCTD Electronic Submissions.
  • Document-level formatting as per the respective HA guidelines.
  • Multilevel quality checks and reviews before sharing or dispatching the Non-eCTD Electronic Submission to the client/HA.
  • NeeS format dossier validation and rectification of errors incurred during submission compilation.
  • Document allocation and simplification.
  • Flexible, easy-to-manage, and secure environment.
  • Template repository.
  • Expertise in global NeeS requirements and NeeS submissions.
  • Automated PDF renditioning and creation of the required table of contents.

Get Ready for Accurate Global NeeS Submissions

Partnering with Leading Organizations

 

Medicinal Products

Publishing and Submission

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Ed Venkat

Global CMC Technical Lead

 

Medical Devices

Publishing and Submission​

USA

Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied. ​

Director of Regulatory Affairs​

France-based, Leading Global Supplier of Women Healthcare Products Company​