IDMP

Let us help you to get IDMP ready

We recognize that compliance with IDMP requirements is a huge challenge for Life Sciences companies increasing the workload on already-stretched regulatory resources. On the other hand, IDMP presents a unique opportunity for substantial long-term improvement of regulatory operations.

That’s why we’ve created a 4-step process to guide you on the journey to IDMP compliance and beyond. Step by step we help you identify where you are in relation to IDMP readiness, and we chart and manage your journey for you.

Benefits

Your path to IDMP success starts here: Book a 1:1 Health Check today

Amplexor 4-Step IDMP Journey

Following your IDMP health check results, we’ll onboard you at the step that best reflects where you are on your IDMP journey.

Kick Start Your IDMP Journey Today

Deep expertise

  • Internal consulting team with senior industry background
  • Deep knowledge of regulatory guidelines and direct involvement in the design and development process
  • Strong partner ecosystem for extensive consulting engagements

Rich experience

  • Industry leadership on XEVMPD – first solution on the market with largest share of gateway submitted records
  • Engagement in IDMP since ISO IDMP standards publication
  • Proven track record on complex data migrations and integrations

Customer relations

  • Customer circle community of industry experts promoting constructive exchange of IDMP information
  • Customer-driven design through direct input and feedback that shapes the IDMP functionality

Long term benefits

  • The target operating model will fundamentally change regulatory operations, enabling better quality and shorten the time to market for the benefit of the patients
  • The standardization of data and processes will significantly contribute to improve operations along the entire value chain

Ease of compliance

  • Our ProductExpert™ IDMP solution is a seamless part of the end-to-end RIM user experience in a familiar user interface

Data-centric processes

  • IDMP is driven by a common master and reference data model shared across the complete Life Sciences Suite
  • Interconnected data model enables transparent and efficient data-driven change management process
  • Improved granularity of structured data brings new potential for automated content creation and other business benefits

Data connectivity

  • Flexible connectors allow configurable connectivity to external data sources
  • Integrated support for AI-based IDMP data extraction
  • SPOR interoperability drives external alignment on reference sources
  • Serve as a central regulatory data hub for your wider company needs
  • Built-in B2B gateway enables direct submission of FHIR messages

Process connectivity

  • IDMP target operating model is a natural part of the end-to-end regulatory information management where IDMP message is submitted together with eCTD sequence
  • Regulatory activity planning & tracking drives both data and content components of the regulatory submissions
  • Direct connection to the submission management capabilities enables automated inclusion of FHIR messages in eCTD sequences

Ease of implementation

  • Upgrade path from existing RIM and XEVMPD implementations, leveraging and transforming existing data
  • Plug&Play solution for new customers on premise or in the cloud with full support for data migration

Future-proof design

  • Configurable data, content and process model allows for simple adjustment to emerging requirements, evolving processes and emerging common practices
  • Regular product releases bring new or enhanced solution capabilities in a frequent pace

Contact us for more details

Connect with us today!