Overview

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Once implementation has been fully completed, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these standards.

The five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616) simplify the exchange of information between regulatory authorities internationally and improve the safety monitoring of medicines by facilitating the assessment of data across classes of medicines and therapeutic areas. ISO finalized the IDMP standards in 2012 and is currently developing implementation guides at international level. Following the implementation of the ISO IDMP standards, the Agency will replace its data-submission format in line with the ISO IDMP standards, terminology and formats.

It is tentatively accepted by European Parliament house to implement IDMP in Europe in multiple Iterations starting with Product information, which includes XEVMPD information and additional fields. However the official confirmation from EMA is not yet announced.

Being a specialist provider of Regulatory Consulting, Operations & Technology Services, Freyr provides efficient and seamless IDMP implementation for its clients. As part of the solution the following data management software solutions and accelerators are being deployed.

  • IDMP Assessment
  • Data level status reports and analytics in terms of availability, accuracy and integrity
 

Freyr IDMP Capabilities

IDMP Assessment

  • Data level status reports and analytics in terms of availability, accuracy and integrity
  • Data Consideration Factors:
    • Availability of data
    • Completeness of the data elements
    • Data compilation status
    • Data submission status
    • Data Quality

IDMP Readiness Support Data Management

  • Provide Data  Management Strategy and Implementation Approach
  • Perform IDMP Readiness , Gap analysis  and Future State Recommendations
  • No need for any technology solution (hosted or on premise)
  • Cost-effective ‘Per- Market Authorization’ or ‘Per-Product’ pricing model

IDMP Software Solution

  • It is intuitive and user-friendly, hosted, on-demand web-based solution that supports authoring, reviewing, approving, publishing, and archival processes with state-of-the-art navigation and user interface components.
  • The software solution offer modular data entry screens based on submission components, enabling granular authoring and component level data entry validation without any dependency on completion of other components.
  • It has an inbuilt function that automatically tracks, captures, and updates any future changes entered.
  • The software solution efficiently monitors, tracks, updates and creates XML files that are compliant with EMA requirements.

Consulting & Compliance Services

  • Provide Data  Management Strategy and Implementation Approach
  • Perform IDMP Readiness, Gap analysis  and Future State Recommendations
  • No need for any technology solution (hosted or on premise)
  • Cost-effective ‘Per- Market Authorization’ or ‘Per-Product’ pricing model
 

Freyr IDMP Features

  • Highly cost-effective secure cloud hosted solution
  • State-of-the-Art Navigation & User Interface
  • Modular Component based Granular Authoring
  • Assured Data Security from creation to storage
  • Flexible and cost-effective Licensing model
  • Record Management, Audit Trail, and Automated Submission
  • Comprehensive Change Management integrated with a robust Record Management System and a unique Reports generation capability
  • Dynamic record updates in line with upcoming guidelines to ensure information data currency and timely submission
  • Online Training and Support

 

To Know More about Freyr IDMP and to take a feature-specific comprehensive product tour.

Request a Demo
 

End-to-end Gap Analysis for IDMP Readiness across Europe

Freyr successfully identified and analyzed data sources to enable client conversant with IDMP requirements and ensured IDMP readiness for compliance across Europe region Download

CLIENT TESTIMONIALS

 
  • During the past several years, I’ve had the pleasure of working with Freyr in the publication, validation and electronic submission of regulatory documentation to the US FDA. The Freyr team has provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.

    President,
    An Independent regulatory and quality consulting company

  • Freyr was a great find indeed. The Freyr Publishing team catered excellent Study Report publishing services. The icing on the cake was their proper coordination, flexibility, dedicated study team, timely and constant communication and subject matter expertise that added to the ease of doing business and towards successfully accomplishing the end goal. This, as well as the fair pricing, is what sets Freyr apart from their competitors. As always, I would recommend Freyr again with no hesitation and should the opportunity arise, we absolutely approach Freyr.

    Project Manager,
    A full-service Clinical Research Organization (CRO)
    Based in Florida

  • We are making great progress and we are impressed with Freyr’s commitment to success and willingness to be flexible; you clearly have capable and experienced people in your organization.

    – VP and Head of Regulatory Operations of a Global Top 5 Pharma & Consumer Company

  • We would like to congratulate Freyr team for their excellent service and error free XEVPRM submission with short notice and well within the regulatory timeframe. We sincerely appreciate their technical skills and their extraordinary and selfless effort.

    We are pleased to acknowledge the timely support and recommend Freyr to everyone who are looking for such services.

    – Vice President, Clinical Research & Pharmacovigilance, Microlabs

  • It has been an absolute pleasure working with Freyr over the past few months. Thank you very much for all the hard work – I could not imagine how difficult it would have been without the team being so proactive and diligent.

    I look forward to returning to work with you in January and an exciting new chapter in our time.

    – GRA Operations Program Manager, Top 5 Global Pharmaceutical Company

  • We have made great progress in a short duration and are impressed with the 162 positive acknowledgements from EMA for the XEVMPD submission project.

    I would like to thank the entire team for their support for critical XEVMPD compliance activities.

    Program Manager, Global Top 5 Pharma and Consumer Health Company

  • I would like to thank the Freyr team for all the support they have provided. The Ops team is very satisfied with the level and quality of services from all the resources that we have on board.

    Thanks to their commitment and discipline, we were able to deliver on all key objectives that had been outlined for us in 2014.

    - Head of Regulatory Operations, Top 5 Global Pharmaceutical Company

  • As we near the completion of a major filing, I would like to thank Freyr and recognize the team resource’s performance. It has been a great addition to our team and throughout all the projects, the involvement has been impeccable, illustrating not only professional demeanor, but in-depth skills, dedication, attention to details, willingness to switch gears and deliver timely results.

    We recognize and acknowledge the exemplary performance and look forward to working together.

    – Manager, Regulatory Operations, Global Top 20, $20+ Bn,
    Pharmaceutical Company

  • Great company for eCTD and regulatory outsourcing is Freyr. I am approaching the end of our first year engagement and we are extremely satisfied with the quality of their resources and leadership. They also have their own suite of tools for publishing eCTD and from what I have seen they offer a very viable publishing solution.

    - Associate Director, Regulatory Technology and Ops,
    Global Top 20 Pharmaceutical Company