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

eCTD implementation Placeholder
eCTD implementation

AE – United Arab Emirates, GCC
AM – Armenia, EAEU “eCTD”
AT
AU – Australia
BE
BG
BH – Bahrain, GCC
BR – Brazil, planned
BY – Belarus, EAEU “eCTD”
CA – Canada
CH – Switzerland
CN – China, Final implementation – Dec-2020?
CY
CZ
DE
DK
EE
EG – Egypt, planned
ES
FI
FR
GB
GR
HR
HU
IE
IS
IT
JO – Jordan
JP – Japan
KE – Kenya, planned
KG – Kyrgyzstan, EAEU “eCTD”
KR – South Korea
KW – Kuwait, GCC
KZ – Kazakhstan, EAEU “eCTD”
LI
LT
LU
LV
MT
NL
NO
OM – Oman, GCC
PL
PT
QA – Qatar, GCC
RO
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
SG – Singapore, planned
SI
SK
TH – Thailand
US – United States
ZA – South Africa

Our Twitter Live Feed

#FDA updates #eCTD Submission Standards from version 4.4 to version 4.5. This new version covers updates made to the US eCTD Validation Criteria. https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e2br3-electronic-transmission-individual-case-safety-reports-implementation-guide-data-elements-and

FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-regional-implementation-guide-e2br3-electronic-transmission-individual-case-safety-reports-drug

Final #FDA guidance with general information on the electronic submission of postmarketing safety reports released. #eSubmission #eCTD https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-submissions-electronic-format-postmarketing-safety-reports?utm_medium=email&utm_source=govdelivery

Load More...