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News: eCTD / NeeS / VNeeS / eCTD Office

TH eCTD Compiler March, 2016

Release Announcement

Full support for Thai eCTD submissions

The Thai Food and Drug Agency started accepting eCTD submission from May 2015 and announced to make eCTD submissions mandatory from 2017.

Applicants can submit their applications with version 1.0 of the Thailand eCTD Module 1 and Regional Specification from 1 January 2016.

The main functionality of the TH eCTD Compiler, part of eCTD Office, is the creation of valid TH FDA electronic dossier submissions along with the lifecycle management.

eCTD Office is fully compliant with TH eCTD specification Module 1 regional information, version 1.0 and Thai FDA eCTD Validation Criteria, version 1.0/01.

Contact us for more info…
TH eCTD Compiler March, 2016

Release Announcement

Full support for NeeS submissions to ALMBiH (Bosnia and Herzegovina)

The Agency for Medicines and Medical Devices BiH announced acceptance of documents for methods of administering / changes / renewal of the authorization in NeeS format.
ALMBIH will accept NeeS submissions for any type of submissions relating to regulatory affairs, including: granting licenses, renewal, variation, transfer or revocation / withdrawal of the license, PSUR and ASMF.

As of 1st July 2015 ALMBih (Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina) is mandating NeeS format for all types of regulatory submissions.

As of February 2015 eCTD Office users are capable of producing valid BA NeeS submissions fully compliant with the ALMBiH NeeS regional validation criteria.


Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.

Contact us for more info…
BA NeeS e-Submissions February, 2015
AU eCTD Compiler July, 2014

Release Announcement

Full support for Australian eCTD submissions

The TGA is currently implementing software to validate, review and process electronic applications for the entry of registered medicines on to the Australian Register of Therapeutic Goods (ARTG).

The TGA is looking for eCTD pilot submissions to test various aspects of the TGA electronic submission system before fully adopting the software in 2015.

As of July 2014 eCTD Office users are capable of producing valid AU eCTD submissions fully compliant with the TGA eCTD regional validation criteria

The main functionality of the AU eCTD Compiler is the creation of valid TGA electronic dossier submissions along with the lifecycle management.


Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.

Contact us for more info…
AU eCTD Compiler July, 2014
CH eCTD Compiler November, 2013

Full support for Swiss Module 1 for eCTD v1.2

As from January 1, 2014 the Swiss Module 1 Specification for eCTD v1.2 must be used for all eCTD submissions.

The Specification and DTD of the Swiss Module 1 Specification for eCTD v1.2 include several amendments , based on change requests and on the implementation of the new Swiss validation criteria v1.2. The validation criteria were aligned to the EU validation criteria v4.1, thus replacing a three category evaluation system (Severity A, B, C) by a two category system (pass / fail and best practice criteria)..

As of November 1, 2013 eCTD Office users are capable of producing valid CH 1.2 eCTD submissions fully compliant with the Swissmedic eCTD Validation Criteria, version 1.2.


Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.

Contact us for more info…
EU eCTD Compiler July, 2013

Full support for EU eCTD M1 Specification v2.0

A new version of the EU eCTD M1 Specification, version 2.0, was published on 1 March 2013 on the EMA eSubmission website.

The version 2.0 enables marketing authorisation applicationsin Croatia and can be used from 1 July 2013.

The EU eCTD M1 Specification v2.0 will be required by EMA and National Competent Authorities in EU from 1 September 2013.

As of July 1st 2013 existing eCTD Office users are capable of producing EU 2.0 eCTD/NeeS submissions fully compliant with EU e CTD Validation Criteria, version 5.0 and EU NeeS Validation Criteria, version 4.0.

Full support for EU Veterinary NeeS v2.2

eCTD Office's VNeeS Compiler is fully compliant with Guideline on eSubmissions for Veterinary Products - version 2.2.


Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.

Contact us for more info…

Full support for South Africa eCTD

Mono Software and PRS announce the new release of the eCTD Office suite, widely used eCTD (NeeS / VNeeS) publishing solution for EU, US (FDA), CA (HCSC), GCC (Gulf Region), CH (Swissmedic), Australia (TGA) and New Zealand (Medsafe) eCTD / NeeS / VNeeS electronic submissions.

The Medicines Control Council (MCC) announced the intention to implement the South African Common Technical Document (ZA eCTD) format which will replace the current MRF1 and any applications still in MBR1 format.

Companies wanting to prepare e-submissions for MCC (Medicines Control Council) can benefit from the easy-to-use, affordable, feature packed tool many companies are using for years (enjoying "stellar support"): eCTD Office!

ZA eCTD Compiler in Action!

eCTD Office fully complies with the Guidance for the submission of regulatory information in eCTD format Module 1 Specification, version 1.0 and MCC eCTD Validation Criteria, version 1.0.


Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.

Contact us for more info…
GCC (SFDA) eCTD Compiler 5 January, 2013

Full support for GCC eCTD and NeeS

Mono Software and PRS announce the new release of the eCTD Office suite, widely used eCTD (NeeS / VNeeS) publishing solution for EU, US (FDA), CA (HCSC), CH (Swissmedic), Australia (TGA) and New Zealand (Medsafe) eCTD / NeeS / VNeeS electronic submissions.

The Drug Sector at the Saudi Food & Drug Authority (SFDA) has recently declared its plan to implement the Electronic Common Technical Document (eCTD).

Companies wanting to prepare e-submissions for SFDA (Saudi Food & Drug Authority) can benefit from the easy-to-use, affordable, feature packed tool many EU/US located companies are using for years (enjoying "stellar support"): eCTD Office!

GCC eCTD Compiler in Action!

eCTD Office fully complies with the Guidance for Registration and the GCC Module 1 Specifications guideline which are available at the SFDA website.

By using the GCC (SFDA) eCTD Compiler, a part of eCTD Office, several topics including easy electronic submission generation, lifecycle management and consistency with the eCTD XML DTD and GC regional validation rules (for all Gulf countries, including: United Arab Emirates, Kingdom of Bahrain, State of Kuwait, Sultanate of Oman, State of Qatar, Kingdom Saudi Arabia and Republic of Yemen) are addressed and solved.


Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.

Contact us for more info…
(FDA) eCTD Compiler January, 2012

Full Support for US FDA eCTD (Including STF Builder)

Mono Software and PRS today announced the major new release of the eCTD Office suite, widely used eCTD (NeeS / VNeeS) publishing solution for EU, US (FDA), CH (Swissmedic) and Australia (TGA) eCTD / NeeS / VNeeS electronic submissions.

The wait is over! Finally, companies preparing e-submissions for FDA (U.S. Food And Drug Administration) can benefit from the easy-to-use, affordable, feature packed tool many EU located companies are using (enjoying "stellar support") for years: eCTD Office!

eCTD Office in the first 2012 release includes the following new features:

  • Full support for US (FDA) eCTD submissions (including STF Builder).
  • Speed up (up to 75%) in validation, publishing.
  • Importing of Envelopes (Admin elements).
  • PDF hyperlink (outlines, annotations) correction and fixing.
  • Validation results grouping/sorting by item/type.
  • and many more improvements...
Contact us for more info…