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

Regulatory Publishing & Submissions

Tackling global submission challenges.

IDMP & Compliance Consulting

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

Medical Writing

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

Regulatory Affairs Consultancy and Support

Celegence provides tailored strategic and procedural support to enable pharmaceutical companies to successfully realize their goals and become launch-ready.

Regulatory Labeling

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

Regulatory Operations & RIMS Management

Registration tracking, planning and reporting on clinical trial authorization applications and marketing authorization applications is a complex task.

CMC Consultancy & Management

Chemistry, Manufacturing, and Controls activities span the entire drug development lifecycle, from preclinical research to post-market surveillance.

Our Medical Device Services
Post Market Surveillance

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

Post-Market Clinical Follow-up (PMCF) Guidance

Meet your PMCF requirements to comply with EU MDR.

EU MDR Gap Analysis

A comprehensive first step towards MDR compliance.

CER / CEP Writing

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

IVDR Consulting

We have the expertise to provide support for all of your In Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation.

Medical Device Consulting

Addressing a changing regulatory environment.

UDI Consulting

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

EU Authorized Representative Services

Manufacturers selling Medical Devices in Europe but located outside of Europe (3rd countries) need to appoint a Europe based Authorized Representative (AR) in order to place a medical device on the EU market as required by the new MDR 2017/745.

Our Cross-Industry Services

Regulatory Intelligence Consulting

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

Combination Products Consultancy

Combination products are regulated by both the pharmaceutical and medical device agencies. The regulatory pathway for combination products is complex and varies by region.

Brexit Support

Supporting your Pharmaceutical, In Vitro Diagnostic and Medical Device regulatory needs for the UK market.

Learning Management

Learning management and business process training.

Center of Excellence (CoE) Model

With the CoE model, your project manager can leverage Celegence’s expertise as an extension of your team for various activities such as medical writing and data management.