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 […]