New requirements for medicine registration in the EU will improve global data exchange between pharmaceutical companies and regulators
June 14, 2021
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 the 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. |
e-Submissions of your documents is no longer the future!
| 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. |
Working with eCTD management software solution eCTDmanager ensures a fast and accurate generation and life cycle management of Your eSubmission.
| Your company’s main advantages for using eCTDmanager are: | ||
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| Contact us to learn more about eCTDmanager with the user interface in Russian in EAEU and CIS countries region! | ||
Press for enquiry here: info@inpharmatis.com! |
Новые требования к подаче сведений при регистрации лекарственных средств в Евросоюзе улучшат глобальный обмен данными между фармкомпаниями и регуляторами
June 10, 2021
Inpharmatis принял участие в работе ПМЭФ-2021
June 04, 2021
Ольга Звонарева возглавит в Inpharmatis направление Regulatory Affairs в России и странах СНГ
May 31, 2021
Inpharmatis appoints new RA Director in Russia & CIS
May 31, 2021
Приведение досье в соответствие с правилами ЕАЭС
May 27, 2021
Bringing the dossier in accordance with the rules of the EAEU
May 27, 2021
Inpharmatis и «АКАДЕМФАРМ» обсудили в Минске перспективы сотрудничества
May 21, 2021
Inpharmatis and “ACADEMPHARM” discussed in Minsk cooperation opportunities
May 21, 2021
Participation in IPhEB Russia 2021
April 19, 2021