Submissions

More countries are implementing eCTD. As a result, more companies are being forced to make decisions regarding how they manage… Read more

We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier. When acquiring an… Read more

The eSubmission roadmap is filled with significant dates that can impact on your business. Here, we look at developments on… Read more

In this article, Christine McGrath, a senior member of our pharmaceutical regulatory affairs team, looks at the issue of Repeat… Read more

The electronic Submission (eSubmission) roadmap has introduced very strict milestones for the mandatory use of eCTD format. Are you aware… Read more

We have referenced it before on our blog: the life sciences sector can learn a lot about outsourcing from the… Read more

For those of us working in the regulatory affairs sector, there is always a deadline to contend with. We deal comfortably with… Read more

The issues faced when translating a non-EU dossier for the EU market is covered in this blog by the CMC… Read more

Looking back on how far we have progressed from the standard paper submission one thing is clear – the age… Read more