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.
End-users like READY! 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! IDMP Product database configuration (RIMS) is handling:
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:
The solution has been developed with the capability of serving pharmaceutical companies holding a large number of Marketing Authorisations.
Ou regulatory database is based on ISO IDMP standards and SPOR controlled vocabularies.
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.
READY! for ePI
Prepare, submit, and maintain documents in ePI with our pre-configured READY! platform.
Product information, Labelling
Increase efficiency in the approval of PI during regulatory procedures.
Regulatory Affairs
Replace Excel spreadsheets, shared drives, and outdated regulatory databases.
Article 57 reporting gateway
Exchange medicinal product information with a click on one button.
Pharmacovigilance
Promote, maintain, and improve compliance with the legal requirements.
Development
Track milestones and store documents created in the development of a new medicine.
Quality Assurance
Manage processes, documents, and products in one integrated platform.
Are you READY! ?
Manage product information, safety data, and documents in one validated environment.
READY! is based around the idea that companies need updated, current information about their products in all of their iterations.
READY! has been developed to meet specific needs of management of structured (IDMP medicinal product information) and unstructured information (documents, forms, records) in pharma industry.
