CambReg has over 4 years experience of eCTD publishing using the fully functional DocuBridge software.
The eCTD is an electronic industry to agency interface:
Pharmaceutical companies have been manually handling huge amounts of paper based documentation for regulatory submissions for decades with multiple copies of these bulky documents being sent to regulatory authorities for review. Handling and archiving of these dossiers leads to problems. The paper process is cumbersome and involves significant investment of time, money and effort. The problem is compounded when reviews and modifications occur throughout the product’s lifecycle. Both industry and regulators recognised the standardising the process and automating submissions was the way forward. The eCTD is the proposed solution to these issues.
The eCTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is an international standard for document submission that is currently recognised by regulatory agencies across the EU, USA and Japan. Organisations have begun moving towards eCTD implementation even though it is not yet compulsory world wide.
There is no difference between CTD and eCTD in terms of scientific, technical and clinical content. However, there are regional differences in the eCTD implementation between ICH regions. At CambReg we keep up to date with regional changes, so you can be sure your electronic submission will be in line with current local requirements.
There are two routes your company can take:
Purchase eCTD software and develop your own in-house solutions
Let CambReg handle your electronic publishing needs.
It is important to balance the high cost of eCTD software, extensive staff training and IT support with the seamless service CambReg can offer.
We are happy to convert your legacy documents in Notice to Applicants (NTA) format or paper CTD to eCTD and electronically publish your MAAs for submission to your chosen Health Authorities in the EU. We can also convert legacy NTA documents to eCTD for FDA submission.
If it is more appropriate we can also prepare a Non eCTD electronic Submission - NeeS