Celegence provides global Regulatory Affairs operational and strategic consulting services and solutions for the life sciences industry

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.

Benefits of our solutions and services include:

eye-optimized Clear Visibility and Control Over a Diverse Products Portfolio
bulb-optmized 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.

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

Why use Celegence for your organization’s needs?

We provide the strategic insight companies need to improve decision making and transform processes.
We offer a flexible and global onshore/offshore resource model that combines technical, operational and strategic expertise to ensure increased efficiency and high quality, while allowing organizations to balance resources and reduce overall cost of ownership.
Our built-in domain expertise including processes and infrastructure allows for a minimized ramp-up period.
Our global approach enables us to leverage local expertise to ensure awareness of local nuances and regulations.
We ensure you stay compliant-ready throughout regional and global regulation changes.

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.

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