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.
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.
Date of application to the EU IVDR
26th May 2022
Our Life Sciences Services
Why Use Celegence For Your Organization’s Needs?
Proud to Help Industry Leaders Help Their Patients, Here’s What They Say
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.”
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
EU MDR Template Creation for a Global Multinational Life Sciences Manufacturer
Case Study: EU MDR Template Creation for a Global Multinational Life Sciences Manufacturer
Establishing a Center of Excellence (CoE) for China eCTD Submissions
Case Study: Establishing a Center of Excellence (CoE) for China eCTD Submissions
Regulatory Publishing
Case Study: Regulatory Publishing Background – Client Needs:
