Organizational readiness assessment for IDMP, xEVMPD and UDI compliance and support activities like data collection, maintenance, submission and governance

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

As Identification of Medicinal Products (IDMP) comes into the horizon for industry, Celegence is offering both a near term focus 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 enables Celegence to help companies prepare for all iterations of IDMP. We are able to 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 consultants work with your regulatory team to smoothly navigate each stage of UDI data submission. Our team will help device companies to 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. Our team is also focusing on new medical devices related regulations globally and help organizations to assess their readiness in terms of data, process and systems to be compliant with the new regulations like EU MDR, UDI, etc.

Celegence can help your business with the following dedicated niche offerings:

  • Provide services to address compliance needs related to Regulatory – IDMP, xEVMPD, UDI and others: this includes data collection and management for compliance and developing a compliance readiness strategy with our team of consultants
  • 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 regulation
  • Subject Matter Expert Advisory for setting up processes for compliance
  • Support both “Outsourced” and “Offshore” models for compliance needs
  • Specialized services like MedDRA Coding, Referential Management, SNOMED, ICD etc. for Pharmaceutical Companies
  • Language specific services

 

Learn more about our niche service offerings:

MEDICAL DEVICES

Global Expertise for Medical Devices

REGULATORY LABELING

Maintenance of Labeling Information, including Safety and Efficacy information

PUBLISHING AND ECTD SERVICES

Global Publishing Services and eCTD Conversion

REGULATORY OPERATIONS MANAGEMENT

Managed regulatory operations related to publishing, submission and regulatory information management for reduced total cost of ownership

REGULATORY INTELLIGENCE SOLUTIONS

Proactive monitoring of regulation changes to assess the impact to your product portfolio

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