The Regulatory Affairs department serves as the central hub of every pharmaceutical company, playing a pivotal role in ensuring compliance, product quality, and regulatory success.
RA professionals are responsible for:
Additionally, they are tasked with:
End-users appreciate READY! for its user-friendly interface, making it effortless to access essential information. It’s not just for regulatory affairs; other parts of the company can also benefit from READY!. It provides the most relevant and up-to-date information about medicinal products and ongoing/planned changes.
READY! keeps users on track with their daily tasks by providing reminders and alerts. This ensures that critical deadlines are never missed.
Our IDMP Product database configuration (RIMS) is handling:
This empowers Regulatory Affairs professionals to focus on their scientific work, rather than wasting unproductive hours populating Excel spreadsheets and searching valid documents.
The result? More work accomplished with less stress.
READY! is a versatile solution for managing:
This solution has been specifically developed to cater to pharmaceutical companies with a substantial number of Marketing Authorizations.
Our regulatory database is built upon ISO IDMP standards and utilizes SPOR controlled vocabularies.
Product Information Management:
Search and Notifications:
Marketing Authorization Applications (MAAs):
Date and Procedure Management:
Support for Specific Requirements:
Collaboration and Reporting:
Regulatory Communication:
Accessing all regulatory information, including products, activities, submissions, tasks, projects, dossiers, and documents, takes mere seconds.
Furthermore, seamless hyperlinks interconnect all data, facilitating effortless navigation from variations to products and archived submissions/sequences.
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Replace Excel spreadsheets, shared drives, and outdated regulatory databases.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 built on the fundamental necessity for companies to have up-to-date and comprehensive information about their products in all their variations.
It has been meticulously developed to address the unique requirements of managing both structured (IDMP medicinal product information) and unstructured data (documents, forms, records) within the pharmaceutical industry.
