We specialize in helping our clients reduce time to market and cost by providing flexible, information-based services. With regulatory expertise that spans all types of products, our global regulatory consultants apply up-to-date robust regulatory intelligence to support product development and submission strategies. Benefits of our solutions and services include clear visibility and control over diverse product portfolios, increased operational efficiency, lowered cost and ongoing regulatory compliance.
Celegence provides a regulatory intelligence platform to support companies with knowledge management, interpretation of local and regional regulations.
This platform enables companies to efficiently make decisions to devise the right regulatory strategy for maintaining and launching products across the globe.
Global Expertise for Medical Devices
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
IDMP & COMPLIANCE CONSULTING
Organizational readiness assessment for IDMP, xEVMPD and UDI compliance and support activities like data collection, maintenance, submission and governance
REGULATORY INTELLIGENCE SERVICES
Proactive monitoring of regulation changes to assess the impact to your product portfolio
Learning management and business process training
ADVISORY AND PROCESS CONSULTING
Consulting services to improve operational efficiency and support strategic initiatives
Our mission is to collaborate with our customers to deliver Regulatory Affairs efficiency that allows them to focus on what matters most: providing exceptional patient value.