Your Partner in Solving Regulatory Challenges in Order to Deliver Exceptional Patient Value

Celegence Provides Global Regulatory Affairs Operational, Strategic Consulting Services & Solutions for the Life Sciences Industry

Introduction to Clinical Evaluation Reports

Latest News

Examine Celegence’s expertise regarding the approach to take in authoring your Clinical Evaluation Reports. While the entire process may seem daunting, your organization must be familiar with a plethora of new, and expanded regulations to maintain compliance with your CERs.

How to Optimize the ROI on your RIMS Solution

Upcoming Webinar

Join Celegence at 10am EST on February 24th to understand the best approaches to take in selecting the right RIMS solution, explore potential integrations with other process areas, and hear Jon Sanford’s expert perspective on the operational challenges facing regulatory affairs teams in adopting a new solution.

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Dedicated to Improving Patient Outcomes Through Intelligent Regulatory Compliance

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.

Achieve Unrealized Efficiencies Through our Groundbreaking Regulatory Intelligence Platform

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.

Pharmaceutical

Medical Devices

Cross-Industry

Our Life Sciences Services

Regulatory Labeling

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

Regulatory Intelligence Solutions

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

MDR Compliance

Our innovative proprietary solution allows our expert medical writing team deliver clinical evaluation reports with enhanced efficiency and improved quality.

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.

Post Market Surveillance

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

Medical Writing

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

UDI Consulting

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

See All Services

Why Use Celegence For Your Organization’s Needs?

Domain Expertise

MDR Regulatory Services Celegence USA

Whether you need support with labeling, publishing, or Regulatory Information Management, our teams have years of experience conducting these activities on behalf of global life sciences companies.
Our leadership has combined experience of 25+ years in the Pharmaceutical industry and 15+ years in Regulatory Affairs.

Learn How Our Platform Can Help Your Regulatory Compliance & Schedule A Demo Now!

Flexible

Increased efficiency for your organization through flexible and scalable solutions.
Options for onshore and offshore model or fully offshore model based on team and project needs.
We support large, mid, and small size life sciences companies in the pharmaceutical, generics, biotech, and medical devices spaces.

Learn How Our Platform Can Help Your Regulatory Compliance & Schedule A Demo Now!

Compliance

MDR Compliance - Life Science Celegence

Our Regulatory Intelligence team keeps our operational team up to date on global as well as country and region-specific requirements for different process areas.
We can help you make informed, proactive Regulatory Strategy decisions by leveraging our technology solution, SRI (Simplified Regulatory Intelligence).

Learn How Our Platform Can Help Your Regulatory Compliance & Schedule A Demo Now!

Infrastructure & Cost Efficiency

MDR Compliance - Life Science Celegence

Our leadership team has decades of experience setting up offshore infrastructure and helping organizations achieve cost efficiencies by setting up an offshore team extension.
We have the unique ability to scale up and down based on volume of work or forthcoming internal and regulation-driven requirements.

Learn How Our Platform Can Help Your Regulatory Compliance & Schedule A Demo Now!

Process

Pharma and Medical Devices Regulatory Services - Celegence

We have established Standard Operating Procedures and SLAs, allowing our teams to ensure high quality and predictable work efficiency.
We define the scope at project outset with your team to set forth clear timelines, quality metrics, and escalation procedures up front make for effective project objectives completion tracking.

Learn How Our Platform Can Help Your Regulatory Compliance & Schedule A Demo Now!

Proud to Help Industry Leaders Help Their Patients, Here’s What They Say

Celegence - Kavo Kerr Client - Life Science Regulations

Dr. Carlos Munoz-Viveros

Director, Clinical Affairs
Kavo Kerr Group, California

“The Celegence team has provided services to meet MDR compliance through high quality CERs in both a timely and cost-effective manner for our Medical Device portfolio. We look forward to a continued partnership in this compliance journey.”

Celegence - Stallergenes Client - Life Science Regulations

Hervé Rique

Director of Safety & Regulatory Information Management
Stallergenes, France

“Celegence’s team serves as an extension of our internal publishing and compliance team and has allowed us to achieve significant time and cost savings in comparison to our previous regulatory partners.”

Resources

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Pharmaceutical Regulatory Publishing - Case Study Celegence

Regulatory Publishing

Regulatory Publishing

Case Study, Pharmaceutical

Case Study: Regulatory Publishing Background – Client Needs:

Celegence Admin2021-02-09T16:46:19+00:00

Cost-efficient and High Quality CEP & CER Writing for Global Medical Device Companies - Feature

Cost-efficient and High Quality CEP & CER Writing for Global Medical Device Companies

Cost-efficient and High Quality CEP & CER Writing for Global Medical Device Companies

Case Study, Medical Devices

Case Study: Cost-efficient and High Quality CEP & CER Writing for Global Medical

Celegence2021-02-09T16:46:01+00:00

Regulatory Labeling - Multi-year Partnership for CCDS - Case Study - Celegence

Multi-year Partnership for CCDS (Core Company Data Sheet) Creation and Updates

Multi-year Partnership for CCDS (Core Company Data Sheet) Creation and Updates

Case Study, Pharmaceutical

Case Study: Multi-year Partnership for CCDS (Core Company Data Sheet) Creation and Updates

Additional Information

Download the latest version of our complete Medical Device capabilities and services.

Medical Device Regulatory Experts MDR Support Brochure - Celegence

How Can We Help?

Celegence can help improve your Regulatory Operations, reach out to us and one of our team members will get in touch with you.