Scienza e Tecnologia
Navignostics Selects Celegence's CAPTIS™ Technology Solution to Support IVDR Compliance
As the EU's IVDR directives went into effect this year, diagnostic manufacturers are now pressed by the complex literature review and data management activities required to write PMS documentation to remain compliant. Celegence's CAPTIS™ cloud solution provides integration with literature and safety databases to automate the creation of PMS documentation, such as Performance Evaluation Reports and Post Market Surveillance Reports. The solution also provides report writing and document management capabilities, which help in the creation and ongoing maintenance of various reports.
Punya Abbhi , Chief Operating Officer at Celegence, said: "We are so glad to support Navignostics in the process of EU IVDR PMS documentation. The CAPTIS™ system will create significant time savings for Navignostics' medical writing process by reducing manual efforts and helping writers organize and analyze data more seamlessly."
"Navignostic's mission of designing client-oriented personalized solutions resonates with our values. Celegence realizes our client's unique demands, and we aspire to provide efficient planning and cost-effective solutions through our innovative technologies."
Dr. Stéphane Chevrier, Co-Founder at Navignostics, said: "We are genuinely excited to work with Celegence and use CAPTIS™ for our IVDR documentation, including literature reviews. I believe the CAPTIS™ platform can better support our compliance efforts related to launching and maintaining focused cancer treatments and medications."
If you would like to learn more about how CAPTIS™ can help organization with regulatory compliance, please contact a Celegence representative today at info@celegence.com. Celegence's expert team is also attending the MedTech Summit US on December 6-8, 2022 , at the Intercontinental Chicago Magnificent Mile, Chicago , so please come by the stand – 2 if you are in the area.
Celegence helps life sciences companies navigate complex global regulatory requirements by providing consulting services and solutions dedicated to regulatory affairs. Celegence supports life sciences customers in the areas of EU MDR compliance, IVDR compliance, regulatory intelligence, RIMS data management, publishing, regulatory labeling including UDI consulting, medical writing and compliance with new regulations for different product portfolios. Celegence's depth of experience and extensive delivery capability allows regulatory affairs and quality teams to operate more efficiently, reduce cost, and improve compliance. For more information, visit www.celegence.com or follow Celegence on LinkedIn.
Rachel Hollos
Marketing Director at Celegence
rhollos@celegence.com
Navignostics is a spin-off company from the University of Zurich , founded in April 2022 , which is leveraging spatial single-cell proteomics to perform advanced analyses of tumor samples. As a start–up active in the personalized medicine field, Navignostics strives to provide innovative solutions to identify the best possible treatment for each cancer patient. In addition, Navignostics provides advanced services to pharmaceutical companies to accelerate cancer drug development and to contribute to companion diagnostic development.
Jana Fischer , Founding CEO:
jana.fischer@navignostics.ch
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