Managing regulatory submissions can feel like solving a big puzzle. With different rules for each country, lots of document formats, and tight deadlines, the process can get overwhelming. That’s where KnowledgeNET comes in—a powerful dossier software that makes regulatory submissions easier and faster. Why KnowledgeNET Is the Best Choice KnowledgeNET isn’t just software; it’s your […]
In the competitive world of pharmaceuticals, the ability to publish eCTD dossiers quickly and accurately can be the difference between securing a market lead and falling behind. Imagine being able to reduce your dossier publishing time by 60%! This isn’t just a dream; with the right tools, it’s entirely achievable. Enter KnowledgeNET, where innovation meets […]
Is your current eCTD viewer helping you manage regulatory submissions efficiently, or is it slowing you down? In the ever-evolving pharmaceutical landscape, having a reliable, intuitive tool is essential to keep up with complex submissions. But does your system give you the full picture? With KnowledgeNET’s eCTD Life Cycle Viewer, you gain more than just […]
What is the CEP 2.0? From the September 2023 this new CEP2.0 will be implemented. Manufacturer and the various organization want to know about what cep2.0 Cep2.0 is new look or the future cep. 1.What will change in the CEP2.0 As part of the implementation of the CEP 2.0, some changes are introduced, which affect […]
Version 4.0 of the electronic Common Technical Document (eCTD) is the upcoming next major version of the electronic submission format. CDER and CBER plan to accept new applications in eCTD v4.0 format in 2023. The current version, v3.2.2, which is used by most global health authorities, including US FDA, EMA, Canada, Japan, and many others. […]
Taiwan Food and Drug Administration (TFDA) released guidelines for eCTD specification. Following countries such as the USA, EU, Japan, Australia, Canada and Switzerland, Taiwan will soon adopt the eCTD standard.
A meeting has been held by US-Food & Drug Administration for explaining the concept of new FDA form 3938 for the submission of Drug Master File to FDA. The agenda for the meeting was to explain the concept of Form 3938, the details of the form, purpose of the form, when should the form 3938 […]
The US Food and Drug Administration’s (FDA or Agency) has announced the date that they will no longer support electronic submissions using the Electronic Common Technical Document (eCTD) Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional Document Type Definition (DTD) Version 2.01 after March 1, […]
TGA updated guidance for the baseline submission for converting their dossier format from paper, Common Technical Document (CTD) or Non-eCTD electronic Submission (NeeS) to electronic Common Technical Document (eCTD).
The UK has left the EU, and the transition period after Brexit comes to an end this year. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021. From 1 January 2021, the MHRA will be […]