Услуги

Компания ИФАРМА осуществляет полное сопровождение клинической разработки лекарственных препаратов от ранних фаз до регистрации и пост-маркетинговых программ.

Regulatory Department is responsible for registering new drugs in Russia and the CIS, applying for chemical substance registration, as well as the registration of dietary supplements and medical devices. As part of these processes, managers prepare registration dossiers, product specification files, instructions for medical use, non-clinical and clinical overviews, etc.

 

The Regulatory Department employees have a long-standing experience in registering new drugs in Russia and the CIS, applying for chemical substance registration, as well as the registration of dietary supplements and medical devices.

Registration services include:

  • review and translation of the available drug documentation;

  • preparation of literature reviews on preclinical and clinical studies;

  • development of regulatory documents;

  • development of instructions for medical use;

  • preparation of a medicinal product registration dossier in accordance with the requirements of the Federal Law of the Russian Federation No. 61-FZ “On Circulation of Medicines”;

  • submission of a document package to the regulatory authorities;

  • interaction with regulatory authorities during the review of the documents submitted until the marketing authorization is granted.

On April 2019, the EEU Board Resolution No.55 "On implementation of the generic procedure "Establishing, maintaining and using the Common Register of the authorized medicinal products within the Eurasian Economic Union"" entered into force.

Until December 31, 2020, the applicant may register medicinal products according to the national rules of the Member States of the EEU. However, such registration certificates will only be valid until December 31, 2025.

The EAEU requirements applicable to a registration dossier, an application and a submission type are established by the EEC Council Resolution No.78 “On the Rules of marketing authorization and assessment of medicinal products for medical use” and the EEC Board Decision No.79 "On the Requirements to the electronic form of applications and documents of the registration dossier submitted when registering and examining a medicinal product for human use" (hereinafter – the Requirements).

One of the requirements for applicants is the electronic form of applications and registration dossier (eCTD).

The eCTD documents shall comply with an XML format in accordance with the structure of the document defined in R.022 "Information on registration file and registration dossier of the medicinal product" as opposed to the eCTD structure.

This makes it impossible to use foreign solutions for FDA and EMA submissions to create an eCTD.

IPHARMA iDossier is designed to automate the process of preparing a registration dossier in XML format in accordance with applicable regulations and the EAEU requirements to electronic form of the dossier submission.

 

The system is a Web application that is compatible with all operating systems and allows you to prepare an XML-document in just three steps:

  1. Filling in the general information on the medicinal product and the submission, and selection of a template depending on the type of medicinal product.

  2. Filling the dossier sections with documents.

  3. Creation of an XML-document.

 

If the registration dossier meets the validation system requirements: checking the filling of the template sections, checking the uploaded document format – an XML-document is created ready for further use and loading into the State Register of Medicinal Products.

We monitor changes in the legislation regarding electronic submissions and update our system if necessary.

 

iDossier – the system for preparation of registration dossiers in the eCTD format.

iDossier automates the preparation of eCTD dossiers in accordance with the EAEU requirements:

  • Creating dossiers based on predefined templates for different types of medicinal product

  • Filling the eCTD sections with documents

  • Dossier validation

  • Exporting the .xml file dossier to the State Register of Medicinal Products or an electronic data carrier

 

From January 1, 2021, the registration of a medicinal product shall only be carried out in accordance with the EAEU procedure.

 

iDossier benefits:

  • The iDossier is accessible via the Internet using any browser

  • Filling a dossier with documents in drag-and-drop mode

  • Automatic filling in the document attributes requiring an XML format

  • Automated online dossier verification

  • Visualization of the current state of the dossier content

  • Large files are uploaded to the dossier in the background

  • Easy integration of iDossier into your company’s registration dossier preparation process

  • Automated check of the new document versions

 

iDossier security:

  • The service is validated for compliance with the completeness, accuracy and reliability of the data and reproducibility of the result

  • A security system is used to prevent unauthorized data access

  • Regular data back-ups

  • The service is deployed on servers in validated data centers located in Russia

  • The service does not store user credentials for accessing data sources

© 2021 IPHARMA

  • Facebook Social Icon
  • LinkedIn Social Icon
  • YouTube Social  Icon
  • Instagram Social Icon