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.
Achieve Unrealized Efficiencies Through our Groundbreaking EU MDR Compliance Platform
Celegence provides a platform to support device manufacturers with the resource burden associated with the EU MDR and IVDR. This innovative platform enables our team to efficiently manage your post marketing surveillance documentation such as Clinical Evaluation Plans and Reports to maintain compliance for the Devices and IVDs that you currently market and plan to launch in the EU.
Celegence Overview
Sonia Veluchamy
CEO
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.
Punya Abbhi
COO
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.
Lakshmeenarayana G Goundalkar
Chief Delivery Officer
Lakshmeenarayana (LGG) is the Vice President of Regulatory Services at Celegence. He is part of Celegence leadership team focused on providing high quality solutions and services for Regulatory Affairs.
Trudy Amiot
Associate General Manager
Trudy is our Senior Regulatory Affairs Scientist at Celegence and has over 25 years of experience in R&D, Quality Assurance, Regulatory Affairs, global production and supply chain of medicine and food.
Innovative Technology Solutions For Life Sciences
Countdown to EU IVDR
In Vitro Diagnostic manufacturers in the European marketplace need to develop and implement strategies in order to be fully compliant. They will otherwise face resource challenges if preparation is left to the end of the transition period.
Last date of application for placing devices on the market according to the IVDD
26th May 2024
Our Life Sciences Services
Why Use Celegence For Your Organization’s Needs?
Proud to Help Industry Leaders Help Their Patients, Here’s What They Say
“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.”
“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.”
“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.”
Resources
In Vitro Diagnostic Regulation (IVDR) Gap Assessment & QMS Support for Class D Devices
In Vitro Diagnostic Regulation (IVDR) Gap Assessment &
Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer
Case Study: Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer