Dedicated to Improving Patient Outcomes Through Intelligent Regulatory Compliance

We specialize in helping our clients reduce their costs 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 and robust regulatory intelligence to support your product development and submission strategies. The benefits of our solutions and services include clear visibility and control over diverse product portfolios, increased operational efficiency, lowered costs, and ongoing regulatory compliance.

Achieve Unrealized Efficiencies Through our Groundbreaking EU MDR Compliance Platform

Celegence provides a platform to support device manufacturers with the resource burden associated with the EU MDR and IVDR. This innovative platform enables our team to efficiently manage your post marketing surveillance documentation such as Clinical Evaluation Plans and Reports to maintain compliance for the Devices and IVDs that you currently market and plan to launch in the EU.

Innovative Technology Solutions For Life Sciences

CAPTIS - EU MDR Compliance Software Celegence
CAPTIS™ – MDR IVDR Compliance Tool

CAPTIS™ is a secure, user-friendly web-based application that assists medical writers with the laborious process of creating regulatory documentation for EU MDR / IVDR compliance such as CERs/CEPs, PMCF plans, and SSCPs.

eCTD Viewer - Dossplorer Celegence - Life Sciences
Dossplorer™ – Viewer for eCTD, NeeS & More

Dossplorer™, our advanced cloud-based dossier management solution eliminates manual steps in the exchange of regulatory dossiers and allows you to share, view and review eCTD, NeeS and other dossier formats from any region and access them in any location!

Countdown to EU IVDR

In Vitro Diagnostic manufacturers in the European marketplace need to develop and implement strategies in order to be fully compliant. They will otherwise face resource challenges if preparation is left to the end of the transition period.

Last date of application for placing devices on the market according to the IVDD

26th May 2024

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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.

Why Use Celegence For Your Organization’s Needs?

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

Kavo Kerr Group - Testimonials Celegence Regulators Life Science
“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.”
Dr. Carlos Munoz-Viveros - Director, Clinical Affairs, Kavo Kerr Group
Astellas Gene Therapies

“I am incredibly satisfied with the work Celegence has done thus far. They communicate well and receive feedback well. I find the team I have been assigned incredibly easy to work with, friendly, and people I genuinely look forward to speaking with once a week.”

Juliana Pherarolis - Project Management and Operations, Astellas Gene Therapies
Stallergenes - Testimonial Celegence
“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.”
Hervé Rique - Director of Safety & Regulatory Information Management, Stallergenes, France

Resources

Additional Information

Download the latest brochures of our capabilities and services.

Medical Device Services Brochure

Medical Device Services Brochure

Pharmaceutical Services Celegence

Pharmaceutical Services Brochure

In Vitro Diagnostics Regulatory Experts - Medical Devices Industry Celegence

In Vitro Diagnostic Services Brochure

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.