READY! for Article 57

READY! for Article 57 and XEVMPD

READY! is a solution built to increase productivity of Marketing Authorisation Holders in collecting, verifying, maintaining and submitting the mandatory data according to Article 57 requirements.

The solution has been developed with a focus on pharmaceutical companies holding more than 100 marketing authorisations. It is comprised of a database, which is in line with the XEVMPD granularity requirements, and it has a user-friendly web interface, strong integrating and reporting capabilities, and an interface to the Eudravigilance Gateway.

The solution also includes capability to manage regulatory activities and electronic submissions for continuing maintenance of product information after July 2nd 2012 (tracking tool).

READY! can be integrated with you existing tracking tools and databases.

What is READY! for Article 57?

READY = REgulatory Affairs DiarY

READY! can be used as a complete Regulatory Information Management system with a database and tracking tool, a submissions management system, and a digital archive of submissions and electronic documents. It can be used in various EU and non-EU regulatory activities for human and veterinary medicinal products and APIs.


READY! will enable you to find information, plan your regulatory activities, prepare comprehensive reports about the status of your regulatory activities, and complete information about your medicinal products.

  • Regulatory database according to Article 57
    Collection and management of the data about medicinal products according to the Article 57 specifications is based on mandatory fields. To collect data on every substance − active or inactive − is possibly the most urgent issue, as the data needs to be gathered from various sources and existing systems, and the work has to start immediately to be finished by the tight deadlines. Regulatory product databases which are not in line with Article 57 are becoming obsolete.

    READY! Provides a complete out-of-box regulatory database which is in line with the daily activities of regulatory affairs departments and enables collaboration with other departments, partners, and consulting companies in collecting the data. READY! fully supports the new xEVMPD data requirements. READY! also fully supports veterinary, OTC, food supplements, API, vaccines, and homeopathic products.
  • Submission of the data in xEVPRM format
    2 July 2012     is the date by which all data must be submitted by each marketing authorisation holder. MAHs are required to provide accurate information about: products, active ingredients, marketing authorisation, etc. You will also need to attach SPC.

    READY! fully supports the automatic creation and submission of the required data in electronic format – xEVPRM through EMA EV Gateway.
  • Regulatory tracking system
    This part of the product focuses on the most efficient way to plan, track, and monitor all regulatory activities. According to the new pharmacovigilance legislation, MAHs have to report all changes to a medicinal product within the mandatory 15 calendar day limit after relevant variations have been approved (after July 2012). Companies need to start adapting their current processes and implement solutions such as READY! to be able to meet the tight deadlines for submitting changes.

    READY! can track all your of regulatory activities and electronic submissions including email, eCTD, NeeS, and xEVPRM. An important part of the solution is making the daily work of regulatory affairs professionals easier. The solution is personalised. All the activities and products they are responsible for are displayed just above all other available information.
  • Searching and reporting
    The most interesting part of READY! for the end users and their managers is its comprehensive searching and reporting capability. All regulatory information (products, activities, submissions, tasks, projects, documents, etc.) is available within seconds. All information is linked through hyperlinks, so it's very easy to jump from a variation to a product, and to submissions. Comprehensive search and reporting abilities will help you find information like: what is registered where; and the status of each product, activity, and document. You will be able to find out what the on-going regulatory activities are, and if activities are finished on time. Complete regulatory activity reports will give you comprehensive information about what person made what changes to your products. READY! will even alert you or your boss about a deadline.

    READY! is a powerful source of your regulatory information. End users like it because it is easy-to-use and getting information is user-friendly. READY! can be used by other departments of your company too, as it will contain the most complete and up-to-date information about the medicinal products.
  • Electronic archive of documents and submissions
    Regulatory affairs experts deal with documents such as SmPCs, PILs, Labeling, and with pharmaceutical dossiers in paper and in electronic formats (NeeS, eCTD, etc.). It is essential to preserve those records and dossiers as authentic and correct versions for the long term. It is also important to have information on which version of the record was submitted to which authority, and the current and past status of each document ('draft,' 'submitted,' 'approved,' 'effective,' 'obsolete,' 'withdrawn,' etc. ). 

    READY! is an proactive approach to archiving and preserving the functions of your regulatory documents and submissions. It can be easly integrated with your existing publishing and document management systems, including those based on MS Sharepoint and Documentum.
  • Time and cost tracking
    We have devoted a significant part of our efforts to support tracking time and costs spent on regulatory activities. Some companies want to collect data about how much time and money they spend on regulatory activities to plan more efficiently. Others need this information to bill their services to their customers.

    READY! has built-in comprehensive time and cost registering and reporting. You will be able to track and plan time the spent for each of your products, or simply find out how much time you need per variation time – on average. For service providers preparing monthly reports for your customers – and bills will be much faster and more efficient.
  • Services
    Collection and migration of the existing data and documents residing in your existing document management systems and other databases, Excel spreadsheets and other tools will be a significant part of your efforts to meet the new requirements. We have a team of experienced IT and regulatory specialists who can gather and integrate the data from from various sources (eCTD publishing tools, Excel spreadsheets, databases, shared disks, document management systems, etc.). Also, validation is a standard part of our services.

    Don't forget, the work must start immediately to be able to meet the deadlines. Our team can help you.

The pharmacovigilance legislation was adopted in the EU in December 2010 and aims to save lives by strengthening the European-wide system for monitoring the safety of medicines. It is the biggest change to the legal framework for human medicines since the Agency was established in 1995, and will be a major focus for the Agency, the EU regulatory network, and its stakeholders in the coming years.

READY! is completely web-based and easy-to-use. The solution has been developed and based on our 15 years experience in regulatory affairs within the pharmaceutical industry.

For more information about Article 57 and XEVMPD, click here.