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