IDMP EASI

IDMP EASI, developed by Ennov, is a plug-and-play connector solution designed to help life sciences organisations achieve IDMP compliance without overhauling their existing Regulatory Information Management (RIM) systems. Built by IDMP experts, EASI is an agnostic solution that extracts structured, validated product data from any RIM or master data system and transforms it into IDMP submission-ready format, enabling regulatory teams to meet EMA deadlines efficiently and accurately.

As EMA requirements for PMS data enrichment become increasingly urgent, IDMP EASI provides a fast, automated path to compliance. The solution eliminates manual data re-entry in the PLM portal, reduces the risk of errors, and gives teams full visibility and control over their data before submission. It also connects directly to EMA's Product Management Service (PMS), allowing users to compare their RIM data against PMS records and prepare enrichment submissions with confidence.

Key Capabilities

• Agnostic RIM Integration: Connects to any existing RIM or master data system without requiring system replacement or significant reconfiguration.
• Automated Data Extraction and Transformation: Seamlessly converts product data into IDMP-compliant format, removing the need for manual rework or data re-entry.
• PMS Connectivity: Directly interfaces with EMA's Product Management Service, enabling side-by-side comparison of RIM data with PMS records to identify and resolve discrepancies at the source.
• Real-Time Validation: Ensures data is fully validated and aligned with EMA's latest requirements before submission, supporting a future-proof compliance posture.
• Submission-Ready Output: Produces fully structured, validated data packages ready for IDMP submission without disrupting existing regulatory workflows.

Why Choose IDMP EASI

• Proven Expertise: Developed by specialists with deep IDMP knowledge, positioning Ennov as an industry leader in IDMP compliance.
• Flexibility: Compatible with any RIM or master data system, making it suitable for organisations regardless of their current technology stack.
• Speed: Enables rapid IDMP readiness without disrupting current workflows or requiring lengthy implementation projects.
• ROI Estimation: A free built-in ROI calculator allows teams to estimate PMS workload and quantify time savings in just five steps.

Business Outcomes

• Significant time savings across the IDMP data enrichment process.
• Full SPOR compliance, ensuring alignment with EMA's substance, product, organisation, and referential data standards.
• Elimination of data duplication across systems and submission channels.
• Readiness for PMS API automation as regulatory requirements evolve.
• Reduced manual errors through end-to-end process automation.

IDMP EASI is designed for regulatory affairs and data management teams at pharmaceutical and life sciences companies facing EMA's PMS enrichment deadlines. The solution integrates with existing infrastructure, supports SPOR compliance, and positions organisations for ongoing PMS API automation, making it a strategic tool for both immediate compliance needs and long-term regulatory data management.