Our Innovative Technology Solutions for your Life Science Organization

Celegence offers regulatory technology solutions that are tailored to the needs of pharmaceutical organizations, medical device and In Vitro Diagnostics manufacturers. 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 help Life Science organizations reduce their costs and time to market to support product development and submission strategies.

Our Technology Solutions

CAPTIS - EU MDR Compliance Software 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.

Features of CAPTIS™:

  • 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

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.

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eCTD Viewer - Dossplorer
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!

Features of Dossplorer™ eCTD Viewer:

  • 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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eCTD Document Templates Dosscriber
Dosscriber™

Our eCTD Document Templates provide a comprehensive solution for creating consistent and compliant regulatory documents. Designed to simplify and accelerate your submission process, our templates are tailored to meet the specific requirements of global regulatory authorities.

Features of eCTD Document Templates:

  • Ready-to-use templates compliant with regional and global regulations

  • Streamlines the creation and review process of regulatory documents

  • Customizable fields to fit specific organizational needs

  • Supports consistency across all submissions, minimizing errors

  • Designed to integrate seamlessly with existing systems and processes

Life Science organizations rely on our eCTD Document Templates to maintain regulatory compliance while reducing the time and effort required to prepare high-quality submissions, ensuring faster time to market.

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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