We worked with a major US manufacturing firm to obtain a CEP. Our team worked closely with the manufacturing company to ensure that the project was completed as efficiently as possible. Recently, the client contacted us to say “Our CEP has been accepted and its certificate granted! Many thanks to Acorn Regulatory for the tremendous […]
The transition from paper based submissions to electronic Common Technical Document (eCTD) has continued in recent years. This is something that we have covered on this website on a number of occasions. The next deadline of note is that of the US Food & Drug Administration (FDA) Drug Master File or DMF deadline. That deadline […]
Now that eCTD is mandatory, you need to ensure that your dossiers are in the eCTD format. In this article we look at mandatory eCTD and what you need to do.
In this article we look at eCTD Baseline Submissions and the issues relating to the January 1st deadline.
The January 1st 2018 eCTD deadline is just one critical date that forms part of the overall eSubmission roadmap that looks at developments of eSubmissions between now and 2020.