Ennov regulatory suite
Data Management Solution
- Simplified IDMP management
- Ensured readiness
- Increased data quality
- IDMP services
Simplify IDMP Management
The ISO Identification of Medicinal Products (IDMP) standards are a set of common, global standards for data elements, formats, and terminology to identify and exchange information about medicinal products.
The introduction and progressive implementation of new IDMP standards means that organizations will need to capture and manage significantly more regulatory data than ever before, which represents a significant challenge to the industry as a whole.
Effective data management involves significant effort, is time-consuming and costly. Ennov IDMP and our IDMP services simplify the process of maintaining your IDMP data while transitioning to the new standard.
Ensure IDMP Data Quality
Ennov IDMP is a quality controlled solution for data management in support of the new IDMP standard.
Leverage your existing data to get a jump start on IDMP. Inventory, identify, cleanse and integrate your data, making your organization IDMP ready.
Mine and extract information contained in your regulatory documentation and other enterprise systems to ensure completeness.
Connected to the Future
Ennov RIM is IDMP ready. We currently support the EMA SPOR Referentials lists (controlled vocabularies) within the system and flag each data element with an “IDMP Term” indicator.
As the SPOR data services specifications evolve, they will be systematically incorporated into the solution – taking full advantage of the Ennov Platform’s flexibility and configurability.
Ennov IDMP is a key component in our comprehensive Regulatory solution suite. In combination with Ennov Doc, Ennov RIM, Ennov Dossier, Ennov Report and our REST API, Ennov has the solution today to whatever challenges tomorrow may bring.
Prepare for IDMP Compliance
Ennov recognizes that compliance with ISO IDMP represents a huge challenge for companies and addressing this challenge places an additional burden on their Regulatory resources.
In an effort to help the industry effectively and efficiently meet the requirements of this new standard, Ennov offers an IDMP Readiness Assessment service as a crucial first step in preparing for IDMP submissions.
Performing the assessment results in a documented evaluation that identifies the various data sources (both structured and unstructured) and provides an accounting of the gaps that will need to be addressed to ensure IDMP compliance.
Aguettant Case Study
Cyrille JEUNE, Regulatory Affairs Systems Manager
World-Class Regulatory Content And Information Management
The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning, product registration management, dossier creation, dossier management and more.