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Advance Your Pharma Business with Our Robust Regulatory Compliance Strategies
- 1Expert Regulatory Consulting with industry-leading expertise.
- 2Advanced Tech Solutions for compliance and efficiency.
- 3Your Extended Team focusing on your core activities.
- 4Custom Compliance Strategies to meet regulatory needs.
The Only Provider to Help You Reduce Compliance Costs Consistently Over Time
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™:
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.
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:
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.
Dosscriber™
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 Dosscriber™ eCTD Viewer:
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.
Wny Choose Celegence
99% first-time acceptance of data & documentation by Notified Bodies and Health Authorities
Improved quality with >95% accuracy over manual processes
Reduce the cost of compliance by 10% each year
Cut time in half on compliance with our AI-enabled expertise
Helping Compliance For:
We’re proud to work with companies like the below and helping them with their regulatory compliance burden.
Are You Looking for Regulatory Consulting Experts?
Learn how your business can increase efficiencies when it comes to regulatory compliance – contact us today to find out more.