Turn IDMP compliance into a competitive advantage

Our IDMP Advisory and Solutions

• Data Mapping & Linking PMS IDs

  Challenge:
  One of the key challenges in regulatory operations is the lack of consistent and accurate mapping of medicinal product identifiers across RIMS and PMS systems. This makes it difficult to reliably identify, compare, and reconcile product records, which can impact data integrity, regulatory compliance, and overall operational efficiency.

  Solution:

  • Data Integration & Alignment
    Consolidate RIMS and PMS datasets into a structured environment to enable standardized processing and traceability.

  • Data Mapping & Linking

    Link PMS IDs with corresponding RIMS records to ensure end-to-end product traceability.

  • Data Quality & Exception Management

    Systematically detect and flag missing, duplicate, or inconsistent identifiers to improve data reliability.

  • Data Verification & Remediation

    Facilitate user review of mapping outputs and drive corrective actions to resolve discrepancies and maintain data accuracy.

  Benefits:
  This solution significantly enhances regulatory data integrity by ensuring accurate and consistent mapping of medicinal product identifiers across RIMS and PMS systems. It improves traceability and reliability of product records and reduces compliance risks.

• Data Verification & Governance

  Challenge:
  Product data is often spread across RIMS, xEVMPD, PMS, and local repositories. Ownership is unclear, data is inconsistent between sources, and verification becomes a manual, recurring effort.

  Solution:

  • Data Mapping: Identifying equivalent fields across different data sources to ensure standardization and consistency.

  • Data Comparison: Assessing fields across systems to uncover alignments, gaps, and discrepancies through automated tools.

  • Data Remediation: Correcting inconsistencies and improving overall data quality through structured cleanup activities.

  • Data Governance: Establishing rules, ownership, and oversight to ensure data accuracy, integrity, and compliance across the organization.

  Benefit:
  A controlled, governed product dataset that supports IDMP compliance in a repeatable way. Your teams reduce manual verification and rework, improve data quality and traceability, and move from one-time clean-up to sustainable maintenance as IDMP and related requirements evolve.

• Data Enrichment & Submission

  Challenge:
  IDMP and PMS work often stalls in execution: required data is scattered across sources, quality varies, and enrichment and submissions become a manual effort. Without a structured and repeatable flow, RA teams end up repeating the same manual effort.

  Solution:
  Our Data Enrichment & Submission approach helps you with:

  • Data Collection: Executing a structured approach to gather information from multiple sources.

  • Data Cleansing: Identifying and resolving errors, inconsistencies, and inaccuracies within existing datasets.

  • Data Submission: Handling enrichment data through the automated PMS data upload using PMS API.

  • Data Management: Managing change requests and submitting PMS updates using the Product User Interface.

  Benefit:
  You accelerate IDMP/PMS enrichment and submission while reducing manual effort and rework. Data quality improves before it reaches PMS, updates become easier to govern and execute, and compliance becomes sustainable through repeatable submission and maintenance.