Optimizing your Team with Regulatory Services and Software

Celegence uniquely combines operational, strategic, and scientific expertise with exclusive technology, to help pharmaceutical, medical device, and IVD clients achieve regulatory compliance in the most time and cost-efficient way. Through leveraging AI and our global expertise, we guarantee 20% cost savings year on year.

Having global presence and coverage, our highly educated and experienced consultants provide unparalleled quality of service for our customers, solving complex and burdensome regulatory challenges. Celegence allows our clients to focus on what matters most: providing exceptional patient value.

Dedicated to Improving Patient Outcomes Through Intelligent Regulatory Compliance

We specialize in helping our clients reduce their costs and time to market by providing flexible, information-based services. With regulatory expertise that spans all types of products, our global regulatory consultants apply up-to-date and robust regulatory intelligence to support your product development and submission strategies. The benefits of our solutions and services include clear visibility and control over diverse product portfolios, increased operational efficiency, lowered costs, and ongoing regulatory compliance.

Celegence Overview

Leading with

We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence who are lead by our leadership team.

Sonia Veluchamy - CEO Celegence
Sonia Veluchamy

Sonia Veluchamy is the CEO and co-founder of Celegence. 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.

Punya Abbhi - COO Celegence
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.

Her 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.

Innovative Technology Solutions For Life Sciences

CAPTIS - EU MDR Compliance Software Celegence
CAPTIS™ – MDR IVDR Compliance Tool

CAPTIS™ is a secure, user-friendly web-based application that assists medical writers with the laborious process of creating regulatory documentation for EU MDR / IVDR compliance such as CERs/CEPs, PMCF plans, and SSCPs.

eCTD Viewer - Dossplorer Celegence - Life Sciences
Dossplorer™ – Viewer for eCTD, NeeS & More

Dossplorer™, our advanced cloud-based dossier management solution eliminates manual steps in the exchange of regulatory dossiers and allows you to share, view and review eCTD, NeeS and other dossier formats from any region and access them in any location!

Get instant access to the Survey that everyone was talking about at RAPS Euro Convergence

The 2024 RAPS & Celegence Regulatory & Readiness Survey

Our Life Sciences Services

Regulatory Publishing & Submissions

Tackling global submission challenges.

IDMP & Compliance Consulting

Organizational readiness assessment for IDMP, xEVMPD and UDI compliance and support activities like data collection, maintenance, submission and governance.

Medical Writing

Specialty knowledge across various product types for multiple regulatory documents and application types.

Post Market Surveillance

Design and implement surveillance processes to increase compliance and reduce risks.

Post-Market Clinical Follow-up (PMCF) Guidance

Meet your PMCF requirements to comply with EU MDR.

Regulatory Affairs Consultancy and Support

Celegence provides tailored strategic and procedural support to enable pharmaceutical companies to successfully realize their goals and become launch-ready.

CER / CEP Writing

CER/CEP writing services to streamline your Clinical Evaluation process.

IVDR Consulting

We have the expertise to provide support for all of your In Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation.

Regulatory Intelligence Consulting

Proactive monitoring of regulation changes to assess the impact to your product portfolio.

Why Use Celegence For Your Organization’s Needs?

Proud to Help Industry Leaders Help Their Patients, Here’s What They Say

Kavo Kerr Group - Testimonials Celegence Regulators Life Science

“The Celegence team has provided services to meet MDR compliance through high quality CERs in both a timely and cost-effective manner for our Medical Device portfolio. We look forward to a continued partnership in this compliance journey.”

Dr. Carlos Munoz-Viveros - Director, Clinical Affairs, Kavo Kerr Group
Astellas Gene Therapies

“I am incredibly satisfied with the work Celegence has done thus far. They communicate well and receive feedback well. I find the team I have been assigned incredibly easy to work with, friendly, and people I genuinely look forward to speaking with once a week.”

Juliana Pherarolis - Project Management and Operations, Astellas Gene Therapies
Stallergenes - Testimonial Celegence
“Celegence’s team serves as an extension of our internal publishing and compliance team and has allowed us to achieve significant time and cost savings in comparison to our previous regulatory partners.”
Hervé Rique - Director of Safety & Regulatory Information Management, Stallergenes, France


Additional Information

Download the latest brochures of our capabilities and services.

Medical Device Services Brochure

Medical Device Services Brochure

Pharmaceutical Services Celegence

Pharmaceutical Services Brochure

In Vitro Diagnostics Regulatory Experts - Medical Devices Industry Celegence

In Vitro Diagnostic Services Brochure

How Can We Help?

Celegence can help improve your Regulatory Operations, reach out to us and one of our team members will get in touch with you.