Reduce time and resources associated with the transition from XEVMPD to IDMP

Ensure data quality via business & technical validation

Simplify and streamline the management of IDMP data

As the partner of choice to over 35 regulatory authorities around the world, EXTEDO's services team is well-equipped with the knowledge and experience to help your organization transition painlessly from XEVMPD to IDMP.

At EXTEDO we understand the fine details of the new IDMP requirements, in fact, a number of our consultants were involved in the definition of the standard itself. Our technical and regulatory consultant team can provide you with an in-depth analysis of your existing processes and technologies and create an accurate assessment of the changes your organization needs to make to ensure IDMP compliance.

A holistic approach to IDMP

EXTEDO’s IDMP transition framework includes the following phases:

  • Strategic planning
  • Regulatory business process consulting
  • System implementation & integration
  • Data analysis, acquisition and management
  • Data transfer
  • Transition to IDMP & IDMP maintenance

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Strategic planning

EXTEDO’s team will conduct an audit to assess your organization’s IDMP readiness and current technology infrastructure. Based on this audit, we conduct a gap analysis, define the project objectives and draft an implementation plan.

Business process consulting

Our team conducts a data quality analysis, assesses the need for integration or migration of IT systems, prioritizes any necessary XEVMPD/IDMP corrections, and ensures that all mandatory IDMP processes are implemented.

Data acquisition and management

Our team supports you with various data acquisition and management tasks including the capture of data from legacy repositories, technical data migration (e.g. downloads from EVWEB), data correction, audit of previously submitted data, and any corrective actions necessary to meet IDMP guidelines. In addition to this, we will help you to ensure that all new mandatory and conditional data elements are correctly implemented and captured.

Data transfer

Once all data has been successfully acquired, audited, and updated, EXTEDO’s team will ensure a smooth and quick data transfer, including data validation and archiving.

IDMP maintenance

Once your transition to IDMP is complete, our commitment to you is that EXTEDO will continue to monitor future developments in both global and regional standards to ensure that you are kept up-to-date with any changes that may affect your business.

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“EXTEDO is a great example of a company that really understands the requirements of the market.”

Director Business Development, Technical Operations and international Business at Genericon

Our Customers

Zambon
IPSEN
VIANEX
Hepalink
PUMA Biotechnology

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