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
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
CEP, CER and PSUR Consulting for a Global Medical Device Manufacturer
CEP, CER and PSUR Consulting Support for a Global Medical Device
Clinical Evaluation and Support with Notified Body Observations for an Emergency-Use Medical Device
Clinical Evaluation and Support with Notified Body Observations
PMS Support Including Execution and Documentation of PMCF Surveys for a Global Medical Device Manufacturer
PMS Support including Execution and Documentation of PMCF