Celegence provides services and solutions to support the Life Sciences industry with regulatory affairs operations and strategy. We aim to help Life Sciences companies navigate complex global regulatory requirements by providing depth of experience and an extensive delivery capability.

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence.

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. We support companies in ensuring regulatory compliance across the globe by providing fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day-to-day operations.

Celegence is a privately owned business headquartered in Chicago, IL with offices in the U.K., Europe, and Bangalore.

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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

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

Learning management and business process training

ADVISORY AND PROCESS CONSULTING

Consulting services to improve operational efficiency and support strategic initiatives

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