Celegence LLC software

The Celegence team has extensive experience writing EU MDR & IVDR compliant documentation including Clinical Evaluation Plans & Reports and Post Market Surveillance Reports. Based on this experience, we have built a groundbreaking proprietary technology solution, CAPTIS™, to streamline MDR & IVDR document creation. With thorough knowledge of all aspects of Medical Writing, we offer an unparalleled end-to-end solution to ensure that you stay on track with post-market surveillance documentation. The CAPTIS™ solution can allow your team to streamline all aspects of your PMS documentation and avoid constant revisions. This not only improves efficiency and quality of medical writing teams, but also allows your RA project manager to quickly understand project status throughout the entire process.

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! Dossplorer™ allows you to share, view and review eCTD, NeeS and other dossier formats from any region and access them from any location. Unlock and explore the true value of your regulatory dossiers in a safe and secure, web-based eCTD viewer. The hybrid cloud/ on-site solution offers you cloud-based software as a service whilst keeping your data privately stored on-site or in a virtual private cloud. Alternatively, Dossplorer™ can be installed as a full on-site solution. Unlock and explore the true value of your regulatory dossiers in a safe and secure, web-based eCTD viewer.