IDMP, xEVMPD, MDR and UDI Compliance

Organizational Readiness Assessment for IDMP, xEVMPD, MDR and UDI Compliance & Support Activities like: Data Collection, Maintenance, Submission and Governance.

Given the scope and complexity of IDMP, xEVMPD, MDR, and UDI compliance, Celegence not only prepares organizations to become regulatory compliant with changing regulations by helping companies collect, convert, and report relevant data; but also, provides strategic support by providing regulatory consultants who can support organizations put in place broader regulatory information management strategies.

As Identification of Medicinal Products (IDMP) comes into the horizon for the industry, Celegence is offering both a short term and a long-term strategic approach to respond to regulatory requirements and establish broader benefits for businesses. Our experience in regulatory operations and xEVMPD submissions enable Celegence to help companies prepare for all iterations of IDMP. We can support companies with readiness assessment, IT and submission strategies, mapping of current xEVMPD fields to IDMP iteration 1 fields and ISO IDMP training.

Our UDI compliance services allow us to manage your medical device product data and distribute it seamlessly to regulatory authorities. Expert Celegence regulatory consultants work with your regulatory team to smoothly navigate each stage of UDI data submission. Our team will help device companies collect and validate their UDI data, build UDI records in HL7 Structured Product Labeling format, submit electronically to the FDA’s Global Unique Device Identifier database and perform ongoing record lifecycle management. Celegence also focuses on regulations for new medical devices globally to help organizations assess their readiness in terms of data, processes, and systems to be compliant with new regulations such as EU MDR and UDI.

Master data on products, organisations and substances to drive (regulatory) processes

IDMP is a set of ISO standards which enables marketing authorization holders (MAH) to take immediate action to reduce the occurrence of adverse events attributed to substandard batches of substances, package materials, finished products, or inferior manufacturers. It also allows the determination of adverse events that could be prevented with improvements in the prescribing information. The standards support various other use cases including regulatory processes, inspections, provision of product information from regulator to other stakeholders like e-prescription, traceability in the supply chain to detect falsified medicines. The data model is also used as a reference and driver for master data management at both agency and industry side.

Improved signal detection and safeguarding of patients

Health Authorities (HA) currently collect information across multiple marketing authorization holders who market generic and similar products. Unfortunately, this is hampered since not the same taxonomy is used across products. Furthermore, the product’s key characteristics are insufficiently captured in databases and scattered over paper or electronic documents. The objective is to improve the ability to perform analyses by using databases and to increase specificity and selectivity of the analyses by using the same taxonomy within- and across MAHs and HAs. Both changes improve signal detection and allow corrective actions to safeguard patients.

Celegence Can Help Your Business with the Following Dedicated Niche Offerings

  • Provide services to address Regulatory compliance for– IDMP, xEVMPD, MDR, UDI, and others: this includes data collection and management to develop a compliance readiness assessment and strategy for your company.
  • Definition of a strategy and roadmap.

  • Comprehensive processes for data management covering data gathering, curation, enrichment, maintenance and governance.

  • Specific services on Data Extraction from various sources in the context of regulations.
  • Subject Matter Expert Advisory for setting up processes for compliance.
  • Support both “Outsourced” and “Offshore” models for compliance needs.
  • Conducting compliance and risk assessments.
  • Specialized services like MedDRA Coding, Referential Management, SNOMED, and ICD for Pharmaceutical Companies.
  • Language specific services.
  • Gap analyses and readiness assessment.

  • Definition of a strategy and roadmap.
  • Proof of Concepts for software solutions.
  • Definition and implementation of business processes and workflows tuned towards IDMP.
  • Data definition and specification of standards and terminologies.
  • Data collection, transformation, and consolidation.

Additional Information

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Pharmaceutical Industry Regulatory Affairs - Celegence
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