To improve the performance and efficiency of business processes, your regulatory affairs group and strategic marketing management teams must have a clear picture of the products statuses within the marketing authorization process. With RIMExpert, the answers you need are always in-hand.
After processing, organizing, and structuring your data, RIMExpert presents it via a configurable output interface that integrates with your existing reporting formats, including dashboards, tables, and exportable dynamic reports. This provides your regulatory affairs department, executive management, and other stakeholders with a complete, real-time overview of current information and upcoming activities. Your teams will be able to better plan and schedule for optimal product life cycle management.
FEATURES
Product portfolio planning and reporting
Planning, tracking, and reporting of regulatory activities
In-process metadata monitoring
On-demand reporting with predetermined content and automatic distribution
Data definition in accordance with XEVMPD and ISO IDMP data models
Automatic generation of different dossier structures (CTD, ACTD, Country-Specific, Medical Device Dossiers, etc.), which can be published in different formats (ECTD, NEES, PDF/paper, etc.)
Seamless integration into the regulatory processes
Secure access based on user permissions
Pre-configured and validation-ready
RIMEXPERT BENEFITS
CENTRALIZE YOUR REGULATORY INFORMATION
Get a clear picture for the planning and scheduling of your business resources and regulatory processes.
DRIVE HARMONIZATION; ENSURE COMPLIANCE
Save time and effort with single data entry. ISO IDMP-ready.
PLAN, TRACK, AND REPORT BETTER AND FASTER
Easy data search and reporting. Easy access to real-time information.
LIFE SCIENCES SOLUTIONS
ProductExpert
ProductExpert is part of AMPLEXOR Life Sciences Suite. It is the first ISO IDMP compliant solution available on the market that enables users to meet IDMP related requirements.
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R&DExpert
R&DExpert is the most advanced and highly flexible solution, which enables users to efficiently manage R&D project and document management, including trial management. One environment. One authoritative source of truth.
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QualityExpert
QualityExpert is part of AMPLEXOR Life Sciences Suite. It enables users to manage all QA/QC processes and documents through a single user-friendly interface in one environment.
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RIMExpert
RIMExpert is part of AMPLEXOR Life Sciences Suite. It is a business intelligence tool designed to standardize the data management process across your company and product lifecycle.
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SubmissionExpert
SubmissionExpert is part of AMPLEXOR Life Sciences Suite. It is the most advanced solution that helps users create, compile, and manage regulatory submissions and publishing.
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