Regulatory Affairs

The Regulatory Affairs department is the central nerve point of any pharmaceutical company.

RA professionals prepare and handle registrations, maintain relevant up-to-date product information, and track various activities including variations and plan renewals.

In addition, they have to handle a huge number of documents, track their status, compile them into dossiers, and publish electronic submissions.

READY! is an essential tool for Regulatory Affairs and brings significant savings and performance improvements.

It replaces all those Excel spreadsheets, shared drives, and outdated regulatory databases.

End-users like it because it is easy-to-use and getting information is user-friendly. It can be used by other parts of the company too, as it contains the most relevant and up-to-date information about the medicinal products and ongoing and planned changes/variations.

Reminders and alerts help users to focus on their daily work and to never miss any deadlines.

READY is a web-based, innovative Regulatory Information Management system (RIMs) handling:

  • Medicinal product information
  • Regulatory activities tracking
  • Article 57 reporting
  • Documents management
  • Dossiers compilation
  • Planning and reporting
  • Digital archive

Using READY! makes it extremely easy to find accurate and up-to-date information, create reports, and prepare plans.
Regulatory Affairs professionals can dedicate their focus to their scientific work, instead of unproductive time spent populating all those Excel spreadsheets.

This translates into more work done with less stress.

READY! can be used for the management of:

  • APIs, formulations
  • Finished products
  • Biomedicines

The solution has been developed with the capability of serving pharmaceutical companies holding a large number of Marketing Authorisations.

READY! provides:

  • Storing product information
  • Review of product information
  • Searching product information
  • Date alerts
  • Automatic notifications
  • Managing various MAAs: National, MRP, DCP, CP
  • Planning and tracking variations, renewals
  • Answers to deficiency letters
  • Commitments tracking
  • Communication with authorities
  • Communication with clients
  • Tracking of various dates
  • Pre-procedural phase handling
  • Planning variations and renewals
  • Compliance check
  • Documents preparation
  • Dossier compilation and tracking
  • CEP support
  • ASMF support
  • eCTD and NeeS sequences archiving
  • Planning slots
  • Tracking costs
  • Post-approval commitment management
  • Regulatory requirements tracking
  • Share information with other departments
  • Easy search and creation of Reports
  • Export data to Excel
  • Automatic alerts and generation of emails
  • Tracking of approved and effective documents
  • Tracking of CEPs and related activities
  • Support for ASMF and related activities
  • Tracking of time spent on various activities
  • Delegating tasks to employees

Searching and reporting

One of the most interesting parts of the solution is searching and reporting.
All regulatory information (products, activities, submissions, tasks, projects, dossiers, and regulatory documents) are available within seconds. All information is linked through hyperlinks, so it’s very easy to jump from a variation to a product and to archived submissions/sequences.

Comprehensive search and reporting abilities will help you find information like:
what is registered where; and the status of each product, activity, and document.

The results of searches can be easily exported to Excel.

Complete regulatory activity reports will give you comprehensive information about which person made changes to your products.

Searches and reports can be done also by employees from other departments. This significantly reduces the workload of RA professionals.