As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence.
Our mission is to collaborate with our customers to deliver Regulatory Affairs efficiency that allows them to focus on what matters most: providing exceptional patient value. We support companies in ensuring regulatory compliance across the globe by providing fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day-to-day operations.
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ISO 27001:2013
Information Security Management System
ISO 9001:2015
Quality Management System
ISO 14001:2015
Environmental Management System
ISO 45001:2018
Occupational Health & Safety Management System
Minority Business Enterprise (MBE) Certified
National Minority Supplier Development Council (NMSDC)
Women’s Business Enterprise (WBE) Certified
Women’s Business Enterprise National Council (WBENC)
Celegence was founded in 2017 by Sonia Veluchamy and Punya Abbhi to bridge the gap between regulatory affairs and operational compliance in the life sciences industry. With a presence in the United States, United Kingdom, Netherlands, and India, Celegence partners with pharmaceutical, medical device, and in vitro diagnostic (IVD) companies to optimize regulatory processes through expert consulting and innovative technology solutions.
Celegence LLC is established with a vision to enhance regulatory compliance and operational efficiency in life sciences
Launch of CAPTIS®, an AI-powered technology platform that revolutionizes medical writing and regulatory compliance
Celegence acquires QDossier, expanding its regulatory technology suite with Dossplorer™ (cloud-based dossier management) and Dosscriber™ (automated document authoring)
Introduction of CAPTIS® AI Copilot, leveraging AI for automated systematic literature reviews and compliance documentation.
Celegence is certified as a Minority-Owned Business by the National Minority Supplier Development Council (NMSDC)
Celegence earns Women's Business Enterprise (WBE) certification from the Women’s Business Enterprise National Council (WBENC), reinforcing its commitment to diversity and inclusion
With a focus on efficiency, innovation, and compliance excellence, Celegence continues to evolve as a trusted regulatory partner for the pharmaceutical and medical device industries.
CHIEF EXECUTIVE OFFICER
With nearly 15 years of industry experience, Sonia envisioned an opportunity to support life sciences companies in bridging the gap between regulatory intelligence and the operational activities associated with compliance. Prior to co-founding Celegence, Sonia Veluchamy was the Managing Director for ArisGlobal, a company that provides technology solutions for close to 200 life science companies worldwide, including top 10 pharmaceutical companies, with the objective of accelerating drug development and ensuring global compliance for its customers. At ArisGlobal, Sonia led the operations for the company and expanded its customer base to 30 of the top 50 global pharmaceutical companies. Sonia received her BA in Economics from the University of Chicago and her MBA in Finance & Entrepreneurship from Columbia Business School.
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CHIEF OPERATING OFFICER
Punya is the Chief Operating Officer of Celegence. Punya is focused on realizing our vision for tech-enabled services, including our AI medical writing platform, CAPTIS®. Punya is highly motivated by the opportunity she sees to improve efficiency for the life sciences industry for developing Regulatory strategies and global expansion. Prior to co-founding Celegence, Punya was a Client Partner for ArisGlobal’s Health Agency customers in Europe.
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CHIEF DELIVERY OFFICER
Roderick Shilshi is a regulatory medical writer specializing in medical device compliance under FDA and EU MDR regulations. He has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments, ensuring alignment with MEDDEV 2.7/1 Rev. 4 and MDR standards.
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Vice President, Business Development - Medical Device
Erin brings over 20 years of experience in medical device and diagnostics, including leadership roles at Medtronic and GE Healthcare.
She has strong expertise in helping clients leverage technology and services to grow their business by solving regulatory, quality and commercial challenges.
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From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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