Celegence Pioneers Industry-First Automation of CMC Module 3 Document Creation with Generative AI
Celegence Recognized on the 2025 Inc. 5000 List of America’s Fastest-Growing Private Companies
13 Aug, 2025
New York – August 13, 2025 – Inc., the leading media brand and playbook for the entrepreneurs and business leaders shaping our future, today announced that Celegence is No. 326 on the annual Inc. 5000 list for Business Products and Services and 3367 on the main 5000 list, the most prestigious ranking of the fastest-growing private companies in America. The list provides a data-driven snapshot of the most successful companies within the economy’s most dynamic segment- its independent, entrepreneurial businesses. Past honorees include companies such as Microsoft, Meta, Chobani, Under Armour, Timberland, Oracle, and Patagonia.
“We are honored to be recognized among such a distinguished group of innovators and entrepreneurs,” said Sonia A. Veluchamy, CEO of Celegence. “This achievement reflects the dedication and hard work of our global team as we continue to push the boundaries of regulatory and AI-powered technology solutions for the life sciences industry. Our rapid growth underscores the increasing demand for advanced regulatory support that balances quality, speed, and cost-efficiency in a complex global market.”
This year’s Inc. 5000 honorees have demonstrated exceptional growth while navigating economic uncertainty, inflationary pressure, and a fluctuating labor market. Among the top 500 companies on the list, the median three-year revenue growth rate reached 1,552 percent, and those companies have collectively added more than 48,678 jobs to the U.S. economy over the past three years.
For the full list, company profiles, and a searchable database by industry and location, visit: www.inc.com/inc5000.
“Making the Inc. 5000 is always a remarkable achievement, but earning a spot this year speaks volumes about a company’s tenacity and clarity of vision,” says Mike Hofman, editor-in-chief of Inc. “These businesses have thrived amid rising costs, shifting global dynamics, and constant change. They didn’t just weather the storm- they grew through it, and their stories are a powerful reminder that the entrepreneurial spirit is the engine of the U.S. economy.”
Inc. will celebrate the honorees at the 2025 Inc. 5000 Conference & Gala, taking place October 22–24 in Phoenix, and the top 500 will be listed in the Fall issue of Inc. magazine.
Celegence, a global leader specializing in regulatory and AI-powered tech solutions for life sciences, offers advanced regulatory affairs services powered by innovative technology for pharmaceutical, medical device, and IVD manufacturers. Leveraging its award-winning proprietary AI platform – CAPTIS® and advanced eCTD viewer – Dossplorer™, Celegence’s experienced subject matter experts help regulatory, and quality teams deliver high-quality results consistently, balancing quality, speed, and cost in a complex regulatory landscape.
Celegence has recently received notable achievements at the TOPRA (an esteemed regulatory organization) Awards for Regulatory Excellence 2024. Specifically, Celegence’s AI-powered regulatory compliance platform CAPTIS® won the Innovation Award, recognizing its transformative use of AI and automation in regulatory affairs. Additionally, Celegence was selected as a finalist in the Innovation Category Dossplorer™, highlighting the company’s leadership in cutting-edge technology solutions for regulatory compliance. These awards underscore Celegence’s commitment to innovation and excellence within the life sciences regulatory sector, allowing manufacturers to achieve compliance efficiency and thereby focus on innovation & patients.
Methodology
Companies on the 2025 Inc. 5000 are ranked according to percentage revenue growth from 2021 to 2024. To qualify, companies must have been founded and generating revenue by March 31, 2021. They must be U.S.-based, privately held, for-profit, and independent—not subsidiaries or divisions of other companies—as of December 31, 2024. (Since then, some on the list may have gone public or been acquired.) The minimum revenue required for 2021 is $100,000; the minimum for 2024 is $2 million. As always, Inc. reserves the right to decline applicants for subjective reasons.
About Inc.
Inc. is the leading media brand and playbook for the entrepreneurs and business leaders shaping our future. Through its journalism, Inc. aims to inform, educate, and elevate the profile of its community: the risk-takers, the innovators, and the ultra-driven go-getters who are creating the future of business. Inc. is published by Mansueto Ventures LLC, along with fellow leading business publication Fast Company. For more information, visit www.inc.com.
About Celegence
Celegence, creator of the CAPTIS® AI platform, provides a comprehensive range of tech-empowered regulatory affairs services for pharmaceutical, medical device, and IVD manufacturers seeking to balance the quality, timelines, and cost of their regulatory compliance. Celegence leverages Dossplorer™, their proprietary advanced eCTD viewer, to improve efficiency in managing submissions and document review. With extensive delivery capabilities and industry expertise, Celegence helps regulatory and quality teams reduce costs and enhance compliance in a dynamic regulatory environment. Headquartered in the United States, Celegence has offices in Europe and India. For more updates, follow Celegence on LinkedIn or learn more at Celegence.com.
For more information, please contact:
Celegence Media Relations
press@celegence.com
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