eCTD publishing, Electronic Submissions

eCTD Manager by Extedo

M.P.C.A. International BV offers CTD to eCTD conversion and subsequent submissions in eCTD format or NeeS format. For eCTD publishing we use the eCTD Manager tools of Extedo, ensuring compliant, validated and timely electronic submissions to regulatory authorities.

eCTD, VET eSubmissions & NeeS applications
CTD to eCTD conversion
Extedo eCTD Manager certified
All EU procedures, Centralised, DCP, MRP, National
About eCTD

Electronic submission services

The eCTD format is mandatory for all submission types related to Marketing Authorisation applications for medicinal products within all EU procedures. M.P.C.A. International ensures your submissions are fully compliant, validated and submitted on time.

NeeS submissions do not use the XML backbone of eCTD and are based on granular PDF files, electronic tables of contents, and electronic navigation. This format was made mandatory in the EU in 2003 and is still in use today in several Member States. However, it is recommended that pharmaceutical companies plan their move to full eCTD submissions as NeeS is considered an interim format.

For more information about our way of working, timelines and prices, please contact us at info@mpca.be.

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Three submission formats

  • eCTD, electronic Common Technical Document. Mandatory for all EU Marketing Authorisation applications.
  • VET eSubmissions, for veterinary medicinal products, developed by the VHG subgroup.
  • NeeS, Non eCTD electronic Submission, still possible for a small number of exceptions.
Our eCTD services

What we offer for electronic submissions

CTD to eCTD Conversion

Full conversion of your existing CTD dossier to eCTD format, including directory structure, XML backbone and MD5 checksum validation.

eCTD Publishing

Professional eCTD publishing via Extedo software, ensuring your submission meets all technical requirements for FAMHP, CBG-MEB, Santé LU, EMA and other EU authorities.

Validation & Quality Control

Full technical validation of eCTD submissions before filing, including XML backbone checks, hyperlink validation and file integrity verification.

Frequently asked questions

eCTD submissions

What is eCTD?
eCTD (electronic Common Technical Document) is the standard electronic format required by health authorities for submitting regulatory dossiers for medicinal products. It organises the dossier into five modules and allows lifecycle management of submissions.
Which submission formats do you support?
We prepare and submit eCTD, VET eSubmissions (for veterinary products) and NeeS applications, for all EU regulatory procedures. We use validated software (EXTEDO) to ensure compliant eCTD submissions.
Can you convert an existing dossier into eCTD format?
Yes. We can convert existing CTD or paper dossiers into compliant eCTD format, ready for submission to the relevant authorities.
Do you handle the publishing and validation of submissions?
Yes. We publish and validate your eCTD submissions to ensure it meets the technical requirements of the receiving authority. Contact our team to discuss your submission.
Get in touch

Need help with your eCTD submissions?

Contact us for more information about our eCTD Manager services, timelines and pricing.

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