idmpREADY

We enable IDMP compliance to drive successful ISO IDMP submissions

The xEVMPD compliance is being replaced with ISO IDMP standards which follow the EMA SPOR data model. This change will ensure a comprehensive coverage of product attributes across all relevant stages of the product life cycle, and will enable superior transparency & traceability. However, this benefit is offset by the almost four-fold increase in the number of product attributes to be managed.
In a continuously evolving regulatory environment, pharma & biotech companies require a reliable partner who brings the right blend of deep regulatory domain expertise and technology knowledge to build solutions that address the challenge of complying with the latest ISO IDMP standards at an optimal TCO.

Critical Challenges for IDMP compliance

Setup of a Robust Centralized Product Data Repository

Ensure Compliance with Continuously Evolving ISO IDMP standards

Implement an Effective Data Governance Process throughout the Product Lifecycle

Navitas enables IDMP compliance by establishing a robust product data model through identifying golden sources of regulatory data, and integrating product life cycle management

Our idmpREADY solution harnesses our proven domain, process and technology expertise in Regulatory Services.

IDMP Rapid Assessment

Assess the current situation, identify the golden sources, and define a roadmap towards compliance

IDMP Implementation

Establish product data model, integrate with product life cycle management systems and with EMA SPOR, and enable IDMP submissions