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.
Are you ready for the mandatory implementation of eCTD format for regulatory submissions? The deadline is quickly approaching and many companies are not prepared. Many others are not even aware that a January 1st 2018 deadline is looming.
We have referenced it before on our blog: the life sciences sector can learn a lot about outsourcing from the airline industry. In particular, companies should consider outsourcing eCTD projects.
For those of us working in the regulatory affairs sector, there is always a deadline to contend with. We deal comfortably with client deadlines every day. However, the new deadlines that are causing the most unease in the life sciences sector are those relating to the electronic common technical document or the eCTD as it is better […]
The issues faced when translating a non-EU dossier for the EU market is covered in this week’s blog by Gillian Prendergast from our pharmaceutical services team.