What is eCTD viewer?

What is eCTD viewer?

Mono eCTD Viewer is a free, stand-alone, easy to use Windows desktop software application for (re-)viewing and understanding the granularity and the lifecycle of electronic submissions prepared in the eCTD, NeeS, VNeeS and other electronic dossier formats. Request Free Copy Purchase Licenses.

What is Rosetta Phoenix?

ROSETTA Phoenix™ eCTD Viewer is a feature-rich yet easy-to-use eCTD viewer for viewing regulated submissions prepared in Electronic Common Technical Document (eCTD) format. It’s easy! ROSETTA Phoenix does not use any jargon or functionality restricted only to those who assemble, compile or publish eCTD submissions.

What does eCTD stand for?

Electronic Common Technical Document
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).

What countries use eCTD?

The countries which are accepting eCTD submissions are:

• US FDA.
• European Medicines Agency (EMA)
• Japan.
• Health Canada.
• Swissmedic.
• China eCTD adoption.

What is eCTD compliance?

eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities (HAs). It provides a harmonized solution to implement the Common Technical Document (CTD) electronically.

How do I publish eCTD?

Preliminary Stages of eCTD Publishing and Electronic Filing

1. Contact the FDA Electronic Submission Support team via email ([email protected]) to inform them of your intent to submit an eCTD and request a sample number.
2. Set up and test an Electronic Submissions Gateway (ESG) account via the FDA website.

What is node extension in eCTD?

Node Extension Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the CTD structure and should be displayed as such when the XML backbone is viewed.

Who developed eCTD?

the International Council for Harmonisation
The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).

What are the types of formats of regulatory submissions?

Electronic Regulatory Submission and Review

• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Investigational New Drug Application (IND)
• Biologics License Application (BLA)
• Master files: Drug Master File (DMF) and Biologics Master File (BMF)
• Emergency Use Authorization (EUA)

Is there an eCTD viewer for Rosetta Phoenix?

ROSETTA Phoenix does not use any jargon or functionality restricted only to those who assemble, compile or publish eCTD submissions. Most users can start using and enjoying ROSETTA Phoenix eCTD viewer without any training. There is no doubt that eCTD publishing software is cumbersome for general users.

What do you need to know about Rosetta Phoenix?

ROSETTA Phoenix ™ eCTD Viewer is a feature-rich yet easy-to-use eCTD viewer for viewing regulated submissions prepared in Electronic Common Technical Document (eCTD) format. It’s easy! You don’t need to learn a new language to use ROSETTA Phoenix.

Is there an embedded version of Rosetta pyramid?

ROSETTA Pyramid provides automatic indexing for eCTD submissions and includes an embedded version of ROSETTA Phoenix to facilitate the navigation of those submissions and the immediate retrieval of their content.

What is the purpose of an eCTD archive?

It is an active archive of a submission (paper or electronic) for immediate retrieval. It provides powerful search tools and immediate access to submission documents offering the best defense in the event of an audit, litigation and legal discovery. With the advent of eCTD, the lifecycle of a document isn’t final after submission.