Electronic dossier submission.
PharmaLex guides you into the future.
Submissions go ELECTRONIC…
…DO YOU FOLLOW?
Processing and managing the increasing amount of submission documentation has been a demanding task ever since the establishment of drug regulatory legislation. With the widespread deployment of electronic systems for document authoring and document management the idea of whole "electronic" submissions has constantly evolved and by now, sending CDs or DVDs rather than piles of binders with printed papers to the authorities has become a widely used alternative. Some agencies have even turned to making "e-"-submissions the mandatory format and refuse to accept paper based submissions at all.
The standard internationally agreed upon for electronic submissions is the electronic Common Technical Document - eCTD. Detailed specifications published by the International Conference on Harmonisation (ICH) explain how to organize the files, folders, navigation aids and meta data to be included in such an e-submission. Yet, the preparation of an eCTD from scratch is cumbersome and usually specific software tools - "publishing programs" - are required. For small and medium sized enterprises the initial investment in software and IT infrastructure is often regarded as the crucial hurdle preventing them from going eCTD. In larger companies the barriers are seen in the integration of the eCTD in their established electronic document workflow and business processes. In both cases one of the main advantages of eCTD - the coverage of a products whole lifecycle - poses additional concern with regard to internal document management.
In the long run such objections are more than compensated by the inherent benefits of the eCTD concept: reduction of paper flow, reduction of physical storage and archiving space, reduced shipping costs, accelerated processing by the agencies, easier navigation through your dossiers, better lifecycle management, and easy viewing. Mind that what ever you want to know about your submissions' documents - in an eCTD they're just a few mouseclicks away. And besides - as agencies make their move to eCTD applicants can hardly afford to stay back.
If you decide to go eCTD but don't want to commit to an in-house soft- and hardware solution, yet, PharmaLex offers a full eCTD submission service. Based on the most established publishing tools we prepare, submit and maintain your electronic dossiers.
If you decide to implement eCTD submissions in your company, PharmaLex offers strategic advice and staff training. Mind that the eCTD is more than a "technical" issue that can be left to your IT department. Its impacts span over all your company's regulatory activities, from the authors of your documents to the "publishers", and may even affect your general regulatory strategies.