Our Innovative Technology Solutions for your Life Science Organization

Celegence offers regulatory technology solutions that are tailored to the needs of pharmaceuticals organizations, medical device manufacturers and In Vitro Diagnostics. The benefits of our technology solutions include clear visibility and control over diverse product portfolios, increased operational efficiency, lowered costs, and ongoing regulatory compliance.

The innovative technologies at Celegence helps Life Sciences organizations reduce their costs and time to market to support product development and submission strategies.

Our Technology Solutions

CAPTIS - MDR Compliance Regulation Technology - Celegence
CAPTIS

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.

CAPTIS™ has been developed in collaboration with our experienced and qualified team of medical writers to address the real time challenges of medical writing and EU MDR / IVDR compliance.

Key features of CAPTIS™ include:

  • Faster Literature Reviews and Adverse Event Analysis
  • Automated data summaries with improved consistency across documentation
  • Right information shared at the right time by stakeholders and within teams
  • Projects stay on track
  • Reduce rework for maintenance reports
  • Simplified review for Notified Bodies
  • Consistent verbiage across documentation
  • Centralized repository for all reusable data
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eCTD Viewer - Dossplorer Celegence - Life Sciences
Dossplorer

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!

Key features of Dossplorer™ eCTD viewer include:

  • Easy import of dossiers and submissions
  • Explore worldwide dossiers using holistic platform views
  • Personalized navigation tree utilizes metadata already present in dossiers
  • Various dossier formats supported
  • Keeps your data completely private with onsite, offsite and hybrid data solutions

Life science organizations are adopting this web-based dynamic technology platform to streamline their publishing activities which supports their compliance and effective data & document management; as required by the regulatory authorities.

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Partnership Program

Become a trusted CAPTIS™ partner and you will have access to the full suite of features and capabilities to enhance your documentation processes.

PARTNERSHIP