eCTD and eCTDmanager in EAEU and CIS

July 23, 2019

eCTD and eCTDmanager in EAEU and CIS

We are currently providing the only solution which is compliant to Rules No. 79 of EAEU by offering quick and efficient e-dossier creation for this region.

We propose rapid implementation of a sophisticated and compliant system of eCTDmanager for your affiliate offices or publishing services for EAEU.

The eCTD standard is now used extensively within Europe and the US and is gradually being rolled out in EAEU and CIS region countries. As this roll-out continues, organizations need to prepare themselves for the new way of working. This will mean additional effort in the short-term, but by ensuring that processes and software are updated and optimized businesses can best take advantage of the opportunities eCTD provides.

Quality eCTD submissions can save your organization money, increase the accuracy of the submission and decrease review times.

Wherever in the world they are based, pharmaceutical companies should be preparing for the arrival of electronic submissions and not wait until final local guidance is released. eCTD-readiness should be a priority for everyone.

Full eCTD information in RUS

e-Submissions of your documents is no longer the future!

Full eCTD information in ENG

eCTDmanager is your complete regulatory dossier assembly and management solution.

It provides you with a complete regulatory dossier assembly and management solution. It is scalable, all-in-one submission management capabilities meet the requirements for both electronic and paper submissions.

eCTDmanager enables you to build, view, validate and publish compliant submissions based on eCTD, NeeS, eCopy, IMPD, CTA, PIP, VNeeS, DMF, ASMF and other regional formats. eCTDmanager significantly improves the quality and consistency of your submissions, proving a powerful hyperlinking and bookmarking engine that allows the detection, notification and correction of broken links.

eCTDmanager enables you to streamline your global submissions by ensuring full compliance with ICH and regional specifications.

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