• eCTD – Electronic Common Technical Document

  • eCTD 4.0 – Next Generation Electronic Submissions

Welcome to Exalon

Your partner for high quality eCTDs, regulatory submission services and EVMPD support

Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business.

We are publishing eCTD submissions for of all types of applications (e.g. medicinal product dossiers, master files) in all regions. Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business.

In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. to Article 57(2) second subparagraph of Regulation 726/2004.

We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry.

Exalon Blog

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Our X Feed

exalon @ectdexperts ·
19 Mar

EMA announces launch of eCTD v4.0 pilot phase III on forward compatibility for EU Centrally Authorised Products https://esubmission.ema.europa.eu/ #eCTD4 #EMA #DrugRegulatory

exalon @ectdexperts ·
13 Mar

Final EU eCTD v4.0 Validation Criteria v1.1 out now – fresh from EMA! Rules updated, changes tracked, file naming best practices included. Applicable 15 July 2026.
Who's already testing v4.0 submissions? Drop your thoughts below https://esubmission.ema.europa.eu/
#eCTDv4 #EMA

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eCTD implemen­tation

interactive map

  • AE – United Arab Emirates – GCC
  • AM – Armenia – EAEU “eCTD”
  • AT – Austria
  • AU – Australia
  • BE – Belgium
  • BG – Bulgaria
  • BH – Bahrain – GCC
  • BR – Brazil – planned
  • BY – Belarus – EAEU “eCTD”
  • CA – Canada
  • CH – Switzerland
  • CN – China
  • CY – Cyprus
  • CZ – Czechia
  • DE – Germany
  • DK – Denmark
  • EE – Estonia
  • EG – Egypt – planned
  • ES – Spain
  • FI – Finland
  • FR – France
  • GB – United Kingdom
  • GR – Greece
  • HR – Croatia
  • HU – Hungary
  • IE – Ireland
  • IS – Iceland
  • IT – Italy
  • JO – Jordan
  • JP – Japan
  • KE – Kenya – planned
  • KG – Kyrgyzstan – EAEU “eCTD”
  • KR – South Korea
  • KW – Kuwait – GCC
  • KZ – Kazakhstan – EAEU “eCTD”
  • LI – Liechtenstein
  • LT – Lithuania
  • LU – Luxembourg
  • LV – Latvia
  • MT – Malta
  • NL – Netherlands
  • NO – Norway
  • OM – Oman – GCC
  • PL – Poland
  • PT – Portugal
  • QA – Qatar – GCC
  • RO – Romania
  • RS – Serbia – planned
  • RU – Russia – EAEU “eCTD”
  • SA – Saudi Arabia – GCC
  • SE – Serbia
  • SG – Singapore – planned
  • SI – Slovenia
  • SK – Slovakia
  • TH – Thailand
  • TW – Taiwan
  • US – United States
  • ZA – South Africa