Maintenance of Labeling Information, including Safety and Efficacy information

Celegence supports life sciences organizations with maintaining labeling information, including safety and efficacy information on country-specific labels.
Our resources have experience updating Core Data Sheets and a strong understanding of the guidelines and expectations around labeling regulations. Our team can completely take over the creation and maintenance of CCDS and CCSIs, as well as keep up with regulation changes that impact labeling requirements.

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

  • Labeling strategy and preparation
  • Compliance analysis and review
  • Legacy product support in every country
  • Updated knowledge of global and regional labeling requirements and highly skilled labeling professionals

Learn more about our niche service offerings:

MEDICAL DEVICES

Global Expertise for Medical Devices

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

IDMP & COMPLIANCE CONSULTING

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

REGULATORY INTELLIGENCE SOLUTIONS

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

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