ARS DOSSIER COMPOSER
ARS Dossier Composer (hereinafter referred to as Program) represents an application for Windows operation system, designated for preparation of a registration dossier of a drug product for human use as per the requirements established for the general market of medicinal products of EAEU, in electronic format as per the structure of electronic document R.022 (revision 1.0.0) approved by the Decree of the Board of the Eurasian Economic Commission dated June 30, 2017 No. 79.
The program has been developed by ARS PharmRussia oriented towards our experience in the field.
Considering the fact that implementation of EAEU electronic format of the dossier in EAEU countries has just been started, many reference books and classifiers have not been approved by the regulatory authority and some contain a set of technical errors. ARS PharmRussia provides regular updates of this application in the course of changes in the regulatory authority requirements.
THE APPLICATION REPRESENTS THE FOLLOWING MAIN POSSIBILITIES:
compilation of XML file with dossier documents for submission to Minzdrav of Russia (Electronic dossier in EAEU format as XML-file should be loaded onto an electronic media along with XML file of an application which should be prepared on the web-site of Minzdrav of Russia);
manual filling of the dossier sections structure with the existing pdf files by a user;
automatic filling of the dossier sections structure based on eCTD ICH;
saving the dossier for its subsequent handling;
storage of a structure of EAEU electronic dossier format as a template of XML structure;
automatic update of a saved dossier structure;
storage of dossier documents versions and status of their submission to Minzdrav of Russia;
the application does not require Internet access, it functions completely autonomously on Clients’ computers which guarantees protection of confidential data;
Being a consulting company in the area of circulation of medicinal products, ARS PharmRussia develops this application being oriented towards its practical experience in the field;
Workgroup members on preparation of the legislation in the sphere of regulation of the general market of medicinal products of EAEU, Eurasian Economic Committee, participate in development of the application;
The main principle of developing this application is provision of all base functional possibilities for preparation of EAEU electronic dossier without overloading with the excessive functional;
The application does not require Internet access, it functions completely automatically on Client computers which provides protection of confidential data;
Competent cost of the application. The application does not require any ERP-platforms and purchase of their licenses.
The license for use with the validity period for 1 year for an organization costs 150 000 RUB (up to 5 workplaces).
Any additional workplace costs 10 000 RUB per year.
1-hour training of users (online) — 10 000 RUB;
1-hour training of users (face to face) — 20 000 RUB;
Free limited version of the software may be provided for testing by request (limited number and size of files in a dossier).
Manual for the software use
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