approach to
efficient and seamless ISO IDMP submissions
Innovations in the system bring along potential advancement for significant improvements in the processes. On the same line, to promptly classify the elements and products implicated in the unpleasant events, the EMA is in the process of revising its earlier guidelines (XEVMPD format) and implementing the ISO IDMP (identification of medicinal products) standards. This led to the beginning of implementation as per the international requirements and the EU principles. The EMA has established an ISO IDMP task force with a focus to give advice on the planning, development, and maintenance of the ISO IDMP standards in the EU region.
Being a specialist provider of Regulatory consulting, operations & technology services, Freyr simplifies data consolidation and provides efficient and seamless ISO IDMP submissions services. Integrated with Regulatory Master Data Management (MDM), Freyr IDMP provides a single source of truth for all the medicinal products enabling clients to manage the product data effectively. Freyr’s enterprise Regulatory information management solution and strategic IDMP consulting, and implementation services enable companies to gain IDMP compliance within the required timelines effectively.
functional highlights
IDMP assessment
IDMP software solution
IDMP readiness support data management
data level status reports and analytics in terms of availability, accuracy and integrity
comprehensive change management integrated with a robust record management system
a unique report generation capability
key features
highly cost-effective secure cloud hosted solution
state-of-the-art navigation & user interface
flexible and cost-effective licensing model
modular component based granular authoring
assured data security from creation to storage
record management, audit trail and automated submission
