IDMP Consultancy

Your Challenge

Complying with the increasing data requirements from both the Health Authorities and internal stakeholders, while ensuring this data is managed in an efficient way is challenging. Additionally, there is the increased complexity in the Regulatory Information Management systems landscape, coupled with the increasing need of system integration and data analytics.
Addressing these challenges requires a deep understanding of the relevant data standards, business processes, involved systems and vendors as well as a knack for organisational change management.

Why Iperion – a Deloitte business

In order to efficiently manage pharmaceutical and medicinal product information, applying data standards is vital. One of the most important data standards is ISO IDMP and we are the global leading expert on IDMP assessment and implementation.
We have unique experience with IDMP, supporting Industry, Regulators and tool vendors in the development and implementation of structured data

We are directly involved in:

• the ISO IDMP discussion
• review of the EU Implementation Guide (IG)
• setup EU-Substance Registration System (EU-SRS)
• leading IRISS forum IDMP topic group
• IDMP assessment and implementation at Industry (top 100 pharma)
• companies and biotech), regulators and tool vendors

Our Solution

Our market-leading IDMP assessment and implementation, consists of the following steps:

1. Awareness creation
Our experts provide tailored sessions which establish appropriate understanding on IDMP, its impact and benefits for all levels within your organisation.

2. Maturity Assessment
We perform an analysis of your data, processes, organisation and technology to define your current and future IDMP needs.

3. Planning & Setup
We deliver a strategic vision for IDMP, based on best-practices and fitting your unique business environment. Accordingly, we establish a pragmatic implementation roadmap for your ideal solution.

4. Solution Implementation
We support the implementation of the desired solution, while making sure that all stakeholders are appropriately engaged, and objectives are achieved.

5. Services
We make sure that you have the correct and complete data for both development and registered medicinal products, comply with the internal and regulator needs. We can additionally strengthen and stabilise your maintenance operations by providing trained experts. Learn more about our managed services.

Our value proposition consists of:

• Industry standard Processes
• Data governance and quality framework
• Tailored use cases for business benefits
• Latest regulatory intelligence
• Implementation experience with RIMS
• Automated data extraction from documents
• Automated data mapping to SPOR
• Data management and migration