# Celegence

> Celegence is a Chicago-area regulatory affairs company that combines specialist consulting, global delivery teams and proprietary software to help pharmaceutical, medical-device and in-vitro diagnostics manufacturers prepare submissions, maintain dossiers and manage recurring compliance work. Its wedge is unusually practical: its own medical writers identify repetitive tasks, engineers turn the best candidates into workflow software, and human experts stay responsible for the regulated output.

- **Founded:** 2017
- **Headquarters:** Downers Grove, United States
- **Founders:** Sonia A. Veluchamy (CEO and Co-Founder), Punya Abbhi (COO and Co-Founder)
- **Team size:** More than 175 employees worldwide as reported by Celegence in October 2025; third-party company profiles commonly place it in the 51-200 range.
- **Products:** CAPTIS, Dossplorer, Dosscriber, Pharmaceutical regulatory services, Medical device and IVD services
- **Notable:** CAPTIS won TOPRA's 2024 Innovation Award; Dossplorer was a finalist in the same category., Ranked No. 3,367 on the 2025 Inc. 5000 with 117% three-year growth and No. 326 in Business Products & Services., Reported notified-body document approvals covering more than 300 unique products or product families.

## Products & services

- **CAPTIS** — AI-enabled web platform for systematic literature review, data extraction, document authoring, post-market surveillance and MDR/IVDR regulatory writing workflows.
- **Dossplorer** — Cloud-based eCTD viewer and dossier manager for importing, searching, reviewing, comparing and exchanging regulatory dossiers and authority correspondence.
- **Dosscriber** — Microsoft Word templates designed to produce consistent, reusable, eCTD-ready regulatory documents without a separate authoring installation.
- **Pharmaceutical regulatory services** — Regulatory strategy and intelligence, RIMS and data governance, labeling, publishing, eCTD submissions, CMC technical writing and lifecycle management.
- **Medical device and IVD services** — EU MDR and IVDR support, clinical and performance evaluation reports, post-market surveillance, UDI/EUDAMED work, technical-file remediation, QMS support and market access consulting.

## Achievements

- CAPTIS won TOPRA's 2024 Innovation Award; Dossplorer was a finalist in the same category.
- Ranked No. 3,367 on the 2025 Inc. 5000 with 117% three-year growth and No. 326 in Business Products & Services.
- Reported notified-body document approvals covering more than 300 unique products or product families.
- Selected by a top-10 global IVD manufacturer after a six-month competitive evaluation in 2025.
- Awarded an EcoVadis Bronze Medal and a grade B in the 2024 CDP climate assessment.
- Certified as a Women's Business Enterprise and a Minority Business Enterprise.
- CEO Sonia Veluchamy was named among Crain's Chicago Business Notable Leaders in Health Care Technology for 2025.

## Latest updates

- **2025-10** — CEO Sonia Veluchamy was recognized by Crain's Chicago Business among its 2025 Notable Leaders in Health Care Technology.
- **2025-08** — Celegence announced that a top-10 global IVD manufacturer selected CAPTIS after a six-month evaluation.
- **2025-08** — Celegence entered the Inc. 5000 at No. 3,367, reporting 117% three-year growth.
- **2025-07** — The company announced generative-AI automation for first drafts of CMC Module 3 documents, with human review retained.
- **2025-04** — Celegence reported a grade B in the 2024 CDP climate assessment.
- **2025-03** — Celegence received an EcoVadis Bronze Medal for sustainability performance.
- **2024-11** — The CAPTIS team won TOPRA's Innovation Award and Dossplorer was named a finalist.

## Links

- Website: https://www.celegence.com/
- LinkedIn: https://www.linkedin.com/company/celegence/
- Twitter/X: https://twitter.com/celegence
- YouTube: https://www.youtube.com/channel/UCryD2QgpDiR4ofZe34J4a3g
- Facebook: https://www.facebook.com/celegence/

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Profile page: https://yespress.io/celegence
Published by YesPress — https://yespress.io
Last updated: 2026-08-20