Overview

Some advancements in the system bring along potential opportunities for significant improvements in the processes. On the same line, to quickly identify the substances and products involved in the adverse events, the EMA amending its earlier regulations (XEVMPD format) is in the process of implementing the ISO IDMP (Identification of Medicinal Products) standards.

Leading to start the 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. The main focus of the implementation is to improve the global monitoring of patient safety by providing universal ID for drugs which can be referenced in ICSR (Individual Case Safety Reports).  Therefore to enable the European regulators track, monitor, suspect, and report the adverse events while marketing their products in the Europe.

Aligning with the ISO IDMP standards, the biggest challenge organizations could face is to capture the humongous amount of Regulatory data (manufacturing, quality, safety, and clinical) pertaining to each medicinal/pharmaceutical product. Enroute, data consolidation and record maintenance may increase organization’s compliance costs and may involve significant risks of inconsistency between submissions and marketed products.

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 System (MDM), Freyr IDMP provides a single source of truth for all the medicinal products enabling clients to effectively manage the product data. Freyr’s Enterprise Regulatory Information Management Solution and strategic IDMP Consulting and Implementation Services enable companies to effectively gain IDMP compliance readiness within the required timelines.

 

Freyr Capabilities

IDMP Assessment

  • Data level status reports and analytics in terms of availability, accuracy, and integrity
  • Data Consideration Factors:
    • Availability
    • Accuracy
    • Complete
    • Unique

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 Advantages

  • Structured strategy for implementing IDMP and create IDMP baseline
  • Support for Source identification, data gap analysis and mapping for IDMP
  • Robust workforce with commitment for IDMP compliance
  • Proven ability to fulfil client requirements with ensured quality
  • Dedicated team involving CMC, PV, Artworks etc. to identify the change management triggers and maintenance of IDMP data

Freyr IDMP Competencies

Regulatory Competencies
X

IDMP Assessment

  • IDMP Landscape Assessment
  • Gap Analysis
  • Suggestions and Recommendations
X

Data Services

  • Data Collection
  • Data Compilation
  • Data Transformation
  • Data Submission
X

Services Consulting

  • Data Compilation Services
  • Data Submission Services
  • Data Validation Services
X

Solution Consulting

  • Customized Solutioning
  • On-site & Hosted model solutions
X

Health Authority Mandates

  • Constant monitoring of HA mandates
X

Support & Maintenance

  • Onsite and offshore base support and delivery models
  • IDMP maintenance services
X

IDMP Strategy & Business Consulting

  • Overall IDMP strategy consulting
  • Centralization programs
  • Establishing business functions
X

IDMP Integration Services

  • Identification of Source systems
  • Integration analysis
  • Integration solutions
  • Data Integration services

 

 

 

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
 
Freyr IDMP

Freyr IDMP

Freyr IDMP 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.

Learn more about Freyr IDMP

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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

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    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