eCTD Office (NeeS / eCTD)

ectd logo-75heCTD Office (www.ectdoffice.com) is the first highly professional and exceptionally intuitive second generation eCTD “off-shelf” software, generally available in the Polish market and designed for creating registration documentation. The combination of the above-mentioned features makes the implementation of the eCTD/NeeS/VNeeS standard become natural evolution in your company, not a long-lasting, unclear and risky process. eCTD Office will enable you to move to a new eDocumentation standard without the necessity of reducing the number of workstations where the software will be available (due to its high cost) and spending many weeks learning to use the software properly. We guarantee that with the simple interface and a number of innovative solutions unavailable in competitive products and used in eCTD Office you will be able to freely move in the eCTD/NeeS/VNeeS environment after only several hours of work, and thus create, validate and verify registration documents for your medicinal products. Furthermore, eCTD Office will ensure you complete compliance with EMA specifications and all other systems to create/validate electronic documents used by various agencies in the European Union. The purchase of the software licence also involves its free updating in case of any changes in European specifications. The reliability and unbeatableness of the program are confirmed by a continually growing circle of users in the EU countries.

 

eCTD Office is standard, independent software that can be used in the Windows environment. eCTD does not require any specific servers/databases or any additional components.

 

eCTD Office can be installed in any kind of Windows operating system (2000/XP and further) or on a server (e.g. Windows Server 2003).

 

ATTENTION!!! PRODUCT DOCUMENTS ARE STORED ON YOUR COMPUTERS ONLY! OUR SOFTWARE IS NOT "REMOTE" SOFTWARE (WWW CONSOLE) AND DOES NOT REQUIRE STORING DOCUMENTATION OUTSIDE YOUR COMPANY, THUS PROVIDING CLASSIFIED DATA SAFETY!

 

As an exclusive distributor in Poland KMJ pharma Sp. z o.o. is offering all types of eCTD Office licences allowing creation/verification/validation of the chosen types of medicinal products dossier – eCTD, NeeS or VNeeS:

eCTD Office – types of licence:

No.

Type of licence

1.

NeeS Compiler

(Creating, validating and publishing NeeS documentation)

2.

NeeS Advanced Compiler

(NeeS Compiler + one-click-import of NeeS/eCTD esubmissions + conversion to PDF [conversion of Word DOC into PDF while exporting documentation])

3.

EU eCTD + NeeS Advanced Compiler

(Creating, validating and publishing EU NeeS and eCTD + documentation life cycle management, converting WORD->PDF)

4.

US (FDA) eCTD

(Creating, validating and publishing eCTD documentation + documentation life cycle management, converting WORD->PDF)

5.

CA (HCSC) eCTD

(Creating, validating and publishing eCTD documentation + documentation life cycle management, converting WORD->PDF)

6.

CH eCTD

(Creating, validating and publishing Swissmedic eCTD documentation + documentation life cycle management, converting WORD->PDF)

7.

Veterinary NeeS Compiler

(Creating, validating and publishing EU VNeeS 1.1 and 2.0 documentation)

8.

AU (TGA) NeeS Compiler

(Creating, validating and publishing AU NeeS documentation, converting WORD->PDF)

9.

GC (SFDA) NeeS Compiler

(Creating, validating and publishing AU NeeS documentation, converting WORD->PDF)

10.

FULL (all kinds of licence available in the eCTD Office package)

(EU/HR/AU/GCC NeeS, US/CA/EU/CH/HR eCTD, EU/HR VNeeS)

11.

eCTD Viewer Basic
(looking through documentation (PDF viewer/eCTD sequence))

12.

eCTD Viewer Professional
(looking through documents/PDF viewer/eCTD sequence /comparing documents/filtering/printing the structure)

Attention:

  • the licence applies to 1 workstation (a computer/a user) and is valid for 365 days counting from the date of giving the activation key,
  • the licence is delivered in the form of registration key (a numerical and digital sequence),

 

The eCTD Office software is regularly updated for free, according to changes in EMA specifications / ICH eCTD and software updating.

Documentation created with eCTD Office meets the highest standards and EMA specifications.

 

eCTD Office – services provided by the software producer (available during the period of the licence):

No.

Services

1.

www training (EN tutorial)

2.

Support by email/VOIP (EN)

3.

Updating to the new version of eCTD Office

 

eCTD Office – services provided by the software distributor – KMJ pharma® Sp. z o.o.:

As a form of support in introducing the new system, we offer you a training session on using the eCTD Office software and the rules of NeeS/eCTD:

Training in eCTD Office (1 day) – eCTD, NeeS, eCTD Office.

Training duration: ~ 6-7 hours.
The training includes:

  • theoretical rudiments for creating electronic documents in NeeS, eCTD format,
  • using the eCTD Office software – NeeS Compiler, eCTD Compiler.

Please send any questions regarding the eCTD Office system to: This email address is being protected from spambots. You need JavaScript enabled to view it.