Regulatory Information Life Sciences Solution


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

With RIMExpert, the answers you need are always in-hand

RIMEXPERT BENEFITS

CENTRALIZE YOUR REGULATORY INFORMATION
CENTRALIZE YOUR REGULATORY INFORMATION

Get a clear picture for the planning and scheduling of your business resources and regulatory processes.

DRIVE HARMONIZATION; ENSURE COMPLIANCE
DRIVE HARMONIZATION; ENSURE COMPLIANCE

Save time and effort with single data entry. ISO IDMP-ready.

PLAN, TRACK, AND REPORT BETTER AND FASTER
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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