What is eCTD submission format?
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.
What is LORENZ docuBridge?
docuBridge is an advanced electronic submission management and regulatory document management system for compiling, publishing, importing, and reviewing. As an eCTD publishing tool, it is also useful for other regulatory submission formats including (V)NeeS, HTML, PDF and paper.
What is Lorenz eValidator?
LORENZ eValidator is the most-used validation software in industry and with agencies, ensuring submission compliance globally. As a validator for eCTD and many other formats, it ensures that all submissions are technically compliant.
What is Module 1 of an eCTD compliant submission?
Module 1 describes the administrative and prescribing information, such as the product information and labeling required by local regulators. For example, Australia’s Therapeutic Goods Administration (TGA) sets its own requirements for dossier format and content for eCTD module1.
What is the latest version of Lorenz Evalidator?
Since April 2018, the major release of all LORENZ products is labeled version 18.1. The second major release of all products in October will be version 18.2.
What is a FDA Form 1571?
The FDA Form 1571 or ‘1571’ is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND. The 1571 is a contractual agreement between the sponsor and the FDA.
What is eCTD publishing?
eCTD publishing is the final compilation of regulatory documents as an electronic submission and typically includes: Assignment of documents to a location within the eCTD modular structure. PDF rendering of the final, hyperlinked documents. Customisation of document headers and footers.
What eCTD viewer does FDA use?
GlobalSubmit VALIDATE
GlobalSubmit VALIDATE is used exclusively by FDA to assess the technical validation criteria of all eCTD submissions passing through its Electronic Submissions Gateway, confirming compliance standards are met.
How many modules are in an IND?
A CTD has five modules: region-specific information (Module 1), summary documents (Module 2), quality-related (CMC) information (Module 3), nonclinical study reports (Module 4), and clinical study reports (Module 5). Historically, submissions to the FDA have been made in paper format.
Does FDA accept paper submissions?
Non-commercial IND submissions (including investigator-sponsored INDs and expanded access INDs) are exempt. After these deadlines, paper submissions or electronic submissions that are NOT in eCTD format will NOT be filed or received unless exempt from the requirement.
Why connect docubridge five with Lorenz?
Connect docuBridge FIVE to other LORENZ and third-party software for a flexible Regulatory Information Management solution. Legacy submissions? Migration is no problem! LORENZ is experienced in migrating entire eSubmission libraries from other systems to ours.
What is the Lorenz evalidator?
The LORENZ eValidator solution was refined into a full product family; structured to meet the needs of companies of varying sizes, and to cover the requirements of differing eSubmission markets worldwide. Perfect for you if you need a quick and easy solution for eCTD validation like EMA validation, US FDA validation or any other region/format.
What happens after I pay with Lorenz ID?
After payment, you will receive an e-mail confirming the purchase and a second e-mail with the invoice. Once the payment process is confirmed, your LORENZ ID account will have the category “ONE” listed. Here you will find your purchased products.