Your Trusted Partner for Regulatory Affairs Excellence
Dr. Balázs Lázár,
Department Head, Global Regulatory CMC & Operation, Gedeon Richter
“We are extremely satisfied with the support and CMC templates provided by Celegence. Thanks to their expertise and the efficiency of the templates, we successfully submitted a business-critical dossier to the EMA with zero major or critical queries – a first for us. This marked a significant improvement compared to past submissions, where major challenges arose without the structured approach Celegence offered. Their collaboration has delivered exceptional results, streamlining our processes, enhancing submission quality, and driving substantial efficiency and cost improvements. We are thrilled with this outcome and look forward to continued success together.
Dr. Balázs Lázár,
Department Head, Global Regulatory CMC & Operation, Gedeon Richter
“We are extremely satisfied with the support and CMC templates provided by Celegence. Thanks to their expertise and the efficiency of the templates, we successfully submitted a business-critical dossier to the EMA with zero major or critical queries – a first for us. This marked a significant improvement compared to past submissions, where major challenges arose without the structured approach Celegence offered. Their collaboration has delivered exceptional results, streamlining our processes, enhancing submission quality, and driving substantial efficiency and cost improvements. We are thrilled with this outcome and look forward to continued success together.
Dr. Balázs Lázár,
Department Head, Global Regulatory CMC & Operation, Gedeon Richter
“We are extremely satisfied with the support and CMC templates provided by Celegence. Thanks to their expertise and the efficiency of the templates, we successfully submitted a business-critical dossier to the EMA with zero major or critical queries – a first for us. This marked a significant improvement compared to past submissions, where major challenges arose without the structured approach Celegence offered. Their collaboration has delivered exceptional results, streamlining our processes, enhancing submission quality, and driving substantial efficiency and cost improvements. We are thrilled with this outcome and look forward to continued success together.
Cloud eCTD viewer and dossier management for electronic publishing and submissions
Our proprietary cloud-based dossier management solution eliminates manual steps in the exchange of regulatory dossiers. It allows you to share, view, and review eCTD, NeeS, and other dossier formats from any region and access them in any location.
The hybrid solution offers you cloud-based software as a service whilst keeping your data privately stored on-site or in a virtual private cloud.
Features of Dossplorer™ eCTD Viewer:
Automated import of dossiers and sequences
SaaS solution
Intuitive search functionality
Explore holistic views across dossiers worldwide
Personalized navigation tree utilizing metadata already present in dossiers
Multiple dossier formats supported
Advanced restrictions
Integrated eCTD viewer with Single Sign-on solutions
All our project leads have a Master degree in a relevant field
All have 10+ years of experience in Pharmaceutical Regulatory domain
Experienced supporting regulatory strategy in 50+ countries
Principal SME & Head RA
Maurice Bancsi
Read More
Read Less
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
