The eCTD is compromised of 5 modules, each of which has its own set of requirements in terms of documents and content. The benefits of eCTD include: eCTD has become a mandatory format requirement for many regulatory health authorities; Europe, the US, Canada, Switzerland, Australia, GCC, South Africa, Japan, Thailand and Jordan as well as […]
All life science companies require approval from Regulatory Health Authorities to place their human, medical device, or veterinary medicinal products on the market. For approval to be granted, the drug application data needs to be submitted in an electronic format, which uses specific software and is structured in the format of an “electronic common technical […]
All life science companies require approval from Regulatory Health Authorities to place their human, medical device or veterinary medicinal products on the market. Electronic common technical document (eCTD) is a mandatory format for submissions to Regulatory Health Authorities, which is set out by the ICH (International Council for Harmonisation). The eCTD standard has evolved since […]
Tired of corrupt documents? Want a bit more automation in your authoring? Maybe it’s time to use a template toolbar created by experts! The team of consultants at ONIX have created a solution that can help with: Pre-defined Heading Styles Embedding #eCTD Numbering Pasting Unformatted Text Copying & Reformatting Tables Predefined and User Custom Document […]
All your eCTD and Regulatory questions answered! Check it out: www.onixls.com/faq/ Did we leave any questions unanswered?
Do you need eCTD submissions compiled with a quick turnaround? Send us your documents in an email or by secure File Transfer Protocol. We will compile the submission in the relevant format, provide it back to you for review, and once you’re happy we will submit using the agency electronic portals. Once done, you will […]
Top 7 Questions to ask Yourself Before Submitting That eCTD Application Working in an eCTD consultancy is probably the best place to see a wide variety of quick mistakes and rather large faux pas from many different sources. Here is what we think are the top questions you need to be asking yourself before sending […]
This is what we do and how we do it! The first step is to send us your documents via secure FTP (or by email). We would then complete word formatting and PDF publishing if necessary. These tasks can be done for submission but we also offer these as stand alone services. We’ll do the […]
Save More Time Using WORD in 2020 Know a more prevalent text editing software than Microsoft Word? Of course you don’t and that’s largely due to the fact that the word processing tool has been in our homes and businesses since the 80’s. For some of us that is around the same time our personal […]
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