Our Niche Life Sciences Services

Celegence provides the global life sciences industry with consulting services and solutions to support regulatory affairs operations and strategy. We specialize in helping our clients reduce cost and time to market 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 lifecycle management and submission strategies. Our blended onshore & offshore model can be tailored to meet each client’s particular needs. Benefits of our solutions and services include clear visibility and control over diverse product portfolios, increased operational efficiencies, lowered cost and ongoing regulatory compliance.

Our Pharmaceutical Services

IDMP & Compliance Consulting

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

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Regulatory Operations Management

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

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Regulatory Labeling

Supporting client requirements from creation to maintenance of global and local drug product labeling.

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Publishing & ECTD Services

Tackling global submission challenges.

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Medical Writing

Specialty knowledge across various product types for multiple regulatory documents and application types.

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Our Medical Device Services
EU MDR Gap Analysis

A comprehensive first step towards MDR compliance.

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UDI Consulting

Manage, maintain, and distribute your product data with precision and efficiency.

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CER / CEP Writing

CER/CEP writing services to streamline your Clinical Evaluation process.

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Post Market Surveillance

Design and implement surveillance processes to increase compliance and reduce risks.

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Medical Device Consulting

Addressing a changing regulatory environment.

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Our Cross-Industry Services
Learning Management

Learning management and business process training.

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Regulatory Intelligence Consulting

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

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