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)
SA – Saudi Arabia – GCC
SE – Serbia
SG – Singapore – planned
SI – Slovenia
SK – Slovakia
TH – Thailand
TW – Taiwan
US – United States
ZA – South Africa

Our Twitter Live Feed

#FDA guidance: Sameness Evaluations in an #ANDA — Active Ingredients https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sameness-evaluations-anda-active-ingredients?utm_medium=email&utm_source=govdelivery

🔵Don’t underestimate the lifesaving ability of cancer screening!

A 🆕 report recommends screening be introduced for lung & prostate cancers and that existing programmes for breast, cervical & colorectal cancer be improved.

👉https://europa.eu/!RbXFTB

#BreastCancerAwarenessMonth

US FDA updates technical validation criteria for #eCTD 4.0 by adding validation rule US-eCTD4-557 https://www.fda.gov/media/150308/download

FDA Electronic Submission Template for Medical Device 510(k) Submissions

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-510k-submissions?utm_medium=email&utm_source=govdelivery

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