IDMP Data Readiness for a Mid-Sized Pharmaceutical Company

Project Summary

A mid-sized pharmaceutical company specializing in allergen products partnered with Celegence to prepare for IDMP compliance. The client faced fragmented data across multiple systems, inconsistent quality, and limited internal expertise on evolving EMA IDMP and PMS requirements. Celegence designed and implemented a comprehensive IDMP data readiness program to ensure regulatory alignment and long-term compliance.

Challenges Faced by the Client

The client faced several obstacles on their path to IDMP compliance:

• Fragmented data spread across multiple internal systems and legacy sources.
• Inconsistent data quality requiring remediation and harmonization.
• Limited internal expertise on evolving IDMP and EU PMS (Product Management Service) requirements.
• Need for an efficient RIM (Regulatory Information Management) system integration to support IDMP data submissions.

Without structured intervention, the client risked delays in compliance, regulatory scrutiny, and operational inefficiencies.

Celegence Solution & Approach:

Celegence supported the client with:

Highlights:

Data Collection: Consolidated product, substance, and organization data from internal systems, regulatory dossiers, and external partners.

Data Remediation: Standardized formats, corrected inconsistencies, and removed duplications in alignment with EMA IDMP data models

Data Enrichment: Populated missing attributes and enhanced data granularity within the client’s RIM system; aligned with SPOR standards

Quality Assurance: Implemented multi-level checks to ensure completeness and accuracy

Cross-Verification: Compared data with EMA’s EV Web and PMS, resolving discrepancies to maintain consistency

SME Support: Provided ongoing guidance on evolving IDMP requirements and conducted training to build internal capabilities