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.
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.