Founders of Celegence: How We Develop Technology for Regulatory Excellence

In the ever-evolving regulatory landscape, Celegence has distinguished itself by leveraging technology to enhance efficiency and deliver high-quality services. In a recent episode of the Gens & Associates regulatory executive podcast series, co-founders Sonia A. Veluchamy and Punya Abbhi discussed the innovative tools and technologies that have been instrumental in their success.

One of Celegence’s flagship products is CAPTIS^®, a medical writing platform designed to streamline the writing process. Punya explained the origins of CAPTIS^®, stating, “It was originally born out of the resource challenges we saw on the MedTech side. The industry was facing EU MDR and IVDR with this huge burden of documentation”. CAPTIS^® has since evolved into a feature-rich platform with modules for template management, master data repositories, and reference management.

Another key tool in Celegence’s technology suite is Dossplorer™, which originated from the legacy Qdossier. Punya highlighted its capabilities, saying, “Our search capability allows for CMC groups to find and make impact assessments much quicker. Instead of spending two weeks, for example, to find information, they’re spending two minutes”. Dossplorer™ supports dossier translations, management of health authority correspondence, and document comparisons, making it an invaluable resource for regulatory intelligence.

Celegence is also at the forefront of integrating AI and automation into its services. Sonia emphasized the potential of these technologies, stating, “We are already taking our team’s input and feedback and leveraging that on a real-time basis as we continue to develop our systems”. By embedding AI in processes like literature search and content creation, Celegence is poised to revolutionize the regulatory space.

Celegence’s commitment to leveraging technology has set it apart as a leader in the regulatory services industry. With innovative tools like CAPTIS^® and Dossplorer™, and a forward-thinking approach to AI and automation, Celegence is well-positioned to continue delivering exceptional value to its clients.