About eCTD
The eCTD is an exchange standard which provides a common format for the transfer of regulatory information from the pharmaceutical industry to National Health Authorities. It is an acceptable or even recommended format for the Health Authorities of Canada, the European Union, Japan, Taiwan and the United States.
The intention is to streamline the benefit-risk assessment, so creating gains in efficiency and eliminating unnecessary delays in the availability of new medicines within Health Authorities as well as within the pharmaceutical industry.

eCTD Challenges
However, the eCTD presents many challenges for industry and approval agencies alike; business processes have to be revised, personnel need to be trained and resources can be temporarily strained. Qdossier offers your company flexible solutions to meet these new challenges.
Our skilled team can produce, maintain and host your regulatory submissions for you. Our expertise can assist you in realising the benefits of the eCTD to your business from the outset.