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.

 

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” (technically different to ICH eCTD) probably mandatory for initial MAAs by 01-Jan-2021
SA – Saudi Arabia – GCC
SE – Serbia
SG – Singapore – planned
SI – Slovenia
SK – Slovakia
TH – Thailand
US – United States
ZA – South Africa

Our Twitter Live Feed

eSubmission Gateway Web Client upgrade - External UAT for all XCOMP users now open. Planned go-live of the new "Syncplicity" Web Client by "late June 2022". #eCTD https://esubmission.ema.europa.eu/esubmission.html

User guide: https://esubmission.ema.europa.eu/gateway/How%20to%20send%20submissions%20via%20the%20Web%20Client%20-%20User%20Guidance%20-%20UAT%20XCOMP.pdf

Also, the Submission Gateway XML delivery file user interface has been updated in a similar way. Furthermore, 2 new submission types have been added. "Companion Diagnostics Consultation" and "Follow-up Companion Diagnostics consultation" https://esubmission.ema.europa.eu/esubmission.html

A new version of the PSUR Repository Industry UI (xml delivery file UI) is now available. Mainly technical update with different look, only possible submission format now #eCTD https://esubmission.ema.europa.eu/psur/psur_repository.html

DADI Conceptual Data Models now available (for Variations) https://esubmission.ema.europa.eu/cessp/cessp.htm

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