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 we use the eCTD Manager tools of Extedo — ensuring compliant, validated and timely electronic submissions to regulatory authorities.
Electronic submission services
The eCTD format is mandatory for all submission types related to Marketing Authorisation for products within all EU procedures. M.P.C.A. International ensures your submissions are fully compliant, validated and submitted on time.
For more information about our way of working, timelines and prices, please contact us at info@mpca.be.
Get a quoteThree submission formats
- eCTD — Electronic Common Technical Document. Mandatory for all EU Marketing Authorisation procedures.
- VET eSubmissions — For veterinary medicinal products, developed by the VHG subgroup.
- NeeS — Non eCTD electronic Submission, still possible for a small number of exceptions.
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, EMA and other authorities.
Validation & Quality Control
Full technical validation of eCTD submissions before filing — including XML backbone checks, hyperlink validation and file integrity verification.
Need help with your eCTD submissions?
Contact us for more information about our eCTD Manager services, timelines and pricing.