the benefits of ectd
ONIX Articles

The Benefits of eCTD

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 […]

what is an ectd submission
ONIX Articles

What is an eCTD submission?

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 […]

ONIX Articles

What is eCTD in Regulatory Affairs?

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 […]

ectd
ONIX Articles

ONIX Articles: II

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 […]

ONIX Articles

ONIX Articles: I

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 […]