Regulatory Information Management & IDMP Solutions
PAREXEL’s End-to-End IDMP Solution
Ensuring compliance with a focus on efficiency, regulatory agencies in Europe, the U.S., and other major global markets will soon require biopharmaceutical companies to provide data submissions using the Identification of Medicinal Products (IDMP) ISO Standards. With the primary goal of improving patient safety, the standards will increase transparency into medicinal registered and investigational products. It will be important for companies to adhere to the new standardized data formats and maintenance processes throughout the product lifecycle.
PAREXEL offers an end-to-end solution to help clients ensure a high level of quality for their IDMP programs.
Taking a proactive approach is the best way to be prepared. Many companies have already begun the planning and readiness stage for the European Medicines Agency (EMA) requirements, which requires submissions to begin in Q1 2017. Initial feedback indicates that the required data is not all readily available in existing systems, requiring that it be mined, developed, codified, formatted, stored and updated with precision and accuracy and in the framework of an effective long-term governance structure.
PAREXEL’s operational expertise, global and local regulatory intelligence and leading edge technology provide a scalable and flexible model for addressing IDMP-related complexities, workloads, and budgets.Our trusted IDMP methodology includes planning for the targeted requirements, combined with proper data and process governance. We define this with five phases for achieving required global data harmonization:
Analysis – Process assessment, data pilot, readiness assessment
Planning – Gap resolution approach, iteration alignment, governance and change management framework
Execution – Process enhancement rollout, integration development, collection processes
Deployment – Agency submissions, acknowledgement processing, realignment
Maintenance and Monitoring – Maintenance of submissions and acknowledgements, monitoring of quality and agency updates
Our global network offers clients:
- Consulting and technology services that support productivity and reduce costs
- Breadth of expertise across regulatory, pharmacovigilance, clinical, manufacturing, and change management
- Access to 600+ regulatory professionals
- An integrated and comprehensive IDMP solution from a proven partner
- A single shared technology platform
- A cost-effective, technology-enabled, and metrics-driven approach
To learn more about our IDMP Readiness Assesment, contact:
+1 781 434 4086
EUROPE & ASIA PACIFIC
+44 (1) 895 61 4632