Regulatory Information Management 

A holistic view to Life Sciences regulatory compliance

The business environment for Life Science companies is demanding and complex. As regulations and standards differ from market to market, organizations face massive volumes of data and multiple systems, processes and functions. 

To improve performance and efficiency, Life Sciences companies need to invest in a streamlined approach across all stages of the product development life cycle. 

Regulatory information as part of future big data architecture

How single-source system allows individuals and teams throughout the organization to access to the most up-to-date regulatory information

Amplexor Life Sciences solutions include a cloud-based RIM solution that integrates content management with registration and submission capabilities to simplify global submissions and accelerate time to market.

This holistic, modular approach to RIM, allows regulatory affairs group and other functions, such as product marketing team, to track and monitor all regulatory developments and their business impacts, within go-to-market processes. 

Besides processing, organizing, and structuring data, Amplexor RIM solution has a configurable interface, including dashboards, tables, and exportable dynamic reports to integrate with existing reporting formats. This provides your 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. 

Centralized regulatory information

Planning business resources and regulatory processes.

Harmonization and compliance

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

Plan, track and report better and faster

Easy data search and reporting. Real-time insights. 

Webinar on-demand

How an integrated Regulatory as a Service (RaaS) approach can help you deploy a more efficient and cost-effective RIM platform

Features

  • Product portfolio planning and reporting
  • Planning, tracking and reporting of regulatory applications and activities
  • In-process regulatory data monitoring
  • On-demand reporting with predefined 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. 
  • Multiformat publishing (ECTD, NEES, PDF/paper, etc.)
  • Health Authority and independent boards interactions (Q&A, Correspondence)
  • Commitments and conditions tracking
  • Product registration management
  • Global regulatory requirements intelligence with submission timelines
  • Secure access based on user permissions and business processes
  • Pre-configured and validation-ready
  • Seamless integration into regulatory processes

Looking for a seamless flow of life sciences regulatory information across the enterprise? 

Contact us now – our industry experts are ready to help