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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

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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

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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

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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

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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 partner with life sciences organizations to streamline Regulatory Operations, delivering global compliance through expert-trained resources, intelligent automation, and cutting-edge technology. Our mission is to reduce complexity, enhance efficiency, and enable our clients to focus on what matters most: delivering exceptional value to patients through safe, effective, and innovative therapies.

  • Vision

    We aim to revolutionize how life sciences organizations manage regulatory compliance—leveraging AI technology to automate complex regulatory content authoring processes so they can focus on delivering life-changing therapies and devices to patients. As pioneers in automating technical and medical writing, we aim to set the industry standard for speed, clarity, and impact. We envision a future where companies bring safe and effective products to market faster, with greater transparency, higher quality, and reduced compliance burden. By transforming compliance into a strategic advantage, we empower our clients to lead with innovation and make 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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