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    As a consulting company, Celegence provides regulatory services and technology solutions for Pharmaceutical, Medical Device, and In-Vitro Diagnostics customers.

    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.

    Corporate Social Responsibility

    Corporate Social Responsibility

    Company News

    Company News

    Certifications & Memberships

    ISO Certifications

    Business Certifications

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      Minority Business Enterprise (MBE) Certified

      National Minority Supplier Development Council (NMSDC)

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      Women’s Business Enterprise (WBE) Certified

      Women’s Business Enterprise National Council (WBENC)

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      EcoVadis Bronze Medal

      Certified for Sustainability Commitment

    Memberships & Awards:

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    • Innovation Award – TOPRA Awards for Regulatory Excellence 2024, for CAPTIS®, an AI-powered regulatory compliance platform
    • Finalist – TOPRA Awards for Regulatory Excellence 2024, for Dossplorer™, an advanced cloud-based dossier management solution
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    Celegence History

    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.

    • 2017

      Celegence LLC is established with a vision to enhance regulatory compliance and operational efficiency in life sciences

    • 2021

      Launch of CAPTIS®, an AI-powered technology platform that revolutionizes medical writing and regulatory compliance

    • 2022

      Celegence acquires QDossier, expanding its regulatory technology suite with Dossplorer™ (cloud-based dossier management) and Dosscriber™ (automated document authoring)

    • 2023

      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)

    • 2024

      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.

    Leadership Team

    • All our project leads have a Master degree in a relevant field
    • All have 10+ years of experience in Life Sciences Regulatory domain
    • Experienced supporting regulatory strategy in 50+ countries
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    CHIEF EXECUTIVE OFFICER​

    Sonia Veluchamy

    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 Abbhi

    Punya Abbhi is the Chief Operating Officer and Co-Founder of Celegence. At Celegence, Punya is focused on realizing our vision for increasing efficiency through technology.Punya’s key responsibility is overseeing the development of our MDR/IVDR compliance platform, CAPTIS®, as well as our Dossplorer™/Dosscriber™ solutions which unlock efficiencies in management of data & documents for the pharmaceutical industry.

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    CHIEF DELIVERY OFFICER

    Lakshmeenarayana Goundalkar

    LGG is part of the Celegence leadership team. He is part of Celegence leadership team focused on providing high quality solutions and services for Regulatory Affairs. He has 18+ years in software product design, development, project management, implementation and SME consulting for global projects related to life sciences. LGG has successfully managed the global delivery teams for Regulatory services and support for 30+ pharmaceutical, medical devices and biologics companies.

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    Vice President, Business Development - Medical Device

    Erin Cosgrove

    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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    Our Policies

    Code of Conduct Policy

    Anti-Bribery and Anti-Corruption (ABAC) Policy

    Prevention of Sexual Harassment (POSH) Policy

    Mission & Vision

    • Mission

      We streamline Regulatory Operations for life sciences organizations, enhancing efficiency and global compliance through expert resources, intelligent automation, and technology, so that our clients can focus on delivering exceptional patient value.

    • Vision

      We aim to revolutionize regulatory compliance in life sciences by leveraging AI to automate complex content authoring processes. This will enable faster, higher-quality product delivery with greater transparency and reduced compliance burden, transforming compliance into a strategic advantage and making a lasting difference in patient outcomes.

    Core Values

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      Client-Centricity

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      We put our clients at the center of everything we do—consistently exceeding expectations and delivering meaningful outcomes.

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      Transparency

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      We foster open, honest communication—internally and externally—to build trust and accountability.

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      Positive Work Culture

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      We cultivate a collaborative, inclusive, and supportive environment where people thrive and do their best work.

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      Integrity

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      We act with honesty, fairness, and respect—always doing what’s right, even when it’s hard.

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      Innovation with Purpose

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      We embrace bold thinking and cutting-edge technology to solve real-world problems and drive meaningful change in healthcare.

    Contact Us Today

    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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