Client Testimonials
Our success is defined by our clients’ achievements. We take pride in delivering the highest quality of regulatory support while building long-lasting partnerships to support our clients on an ongoing basis.
See What Our Clients Are Saying
“I want to thank your team for the valuable contribution and partnership during this project. It’s noteworthy to mention that the clinical assessment phase was passed the BSI assessment without any questions / additional information being asked. This is primarily the CER/CEP evaluation and risk assessment.
Thank you the entire “Celegence Team” for the timely delivery of quality work which is continue to be accepted by EU Notified Bodies.”
Shirantha Samarappuli, PhD – Vice President – Regulatory Affairs & Quality Management Systems
“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
“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,
“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,
“I would highly recommend Celegence for any EU MDR compliance related projects.”
“I reached out to Celegence to help my company prepare for an upcoming MDR assessment for CE Certification in late April. The timeline was very short and the deliverables requested were substantial. We needed a rewrite of our Clinical Evaluation Report (CER) as well as a Gap Analysis of our Technical Documentation to the new EU MDR within 2 months. The feedback was very detailed and actionable allowing us to quickly address all deficiencies within a week. Similarly, the CER prepared was top notch with all of the appropriate hooks in place to allow compliance with the new EU MDR. All in all, I would highly recommend Celegence for any EU MDR compliance related projects.”
Jim Talbot – Vice President, RA/QA,
“Celegence’s expert publishing team allowed us to submit our briefing book and other documents to the US FDA in eCTD format, thereby reducing dependencies on our core team and allowing them to focus on more strategic initiatives.”
Frederick Cope – Executive,
“I reached out to Celegence with an urgent project that we could not complete internally. Celegence immediately established a team of experts to strategize next steps. They started project execution nearly overnight and worked seamlessly with our internal team. I would strongly recommend Celegence and their team of experts to anyone facing resource challenges or regulatory hurdles.”
Miriam Tenorio – Vice President, Marketing,
“I am very happy with the service received and with the finished Clinical Evaluation Report, which was exactly what we needed. The fact that you have a dentist on staff made the whole document authoring process work very well.”
Ben Jaggers – Managing Partner,
“Our experience working alongside Celegence, from Account Manager through to Leadership, has been uniformly excellent! We would like to thank them all, in particular the SMEs for their support of critical regulatory compliance activities. We are truly impressed with Celegence’s flexible approach and highly knowledgeable team.”
Matt Garrity – Director of Quality,
“We had a very good experience working alongside the Celegence medical device services team when drafting our clinical evaluation processes, and truly appreciate their highly professional and cooperative global regulatory experts. They took great care in understanding our CER/CEP and PSUR submission requirements.”
Marcel Borger – VP Quality & Regulatory Affairs,
“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
“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,
“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,
“I would highly recommend Celegence for any EU MDR compliance related projects.”
“I reached out to Celegence to help my company prepare for an upcoming MDR assessment for CE Certification in late April. The timeline was very short and the deliverables requested were substantial. We needed a rewrite of our Clinical Evaluation Report (CER) as well as a Gap Analysis of our Technical Documentation to the new EU MDR within 2 months. The feedback was very detailed and actionable allowing us to quickly address all deficiencies within a week. Similarly, the CER prepared was top notch with all of the appropriate hooks in place to allow compliance with the new EU MDR. All in all, I would highly recommend Celegence for any EU MDR compliance related projects.”
Jim Talbot – Vice President, RA/QA,
“Celegence’s expert publishing team allowed us to submit our briefing book and other documents to the US FDA in eCTD format, thereby reducing dependencies on our core team and allowing them to focus on more strategic initiatives.”
Frederick Cope – Executive,
“I reached out to Celegence with an urgent project that we could not complete internally. Celegence immediately established a team of experts to strategize next steps. They started project execution nearly overnight and worked seamlessly with our internal team. I would strongly recommend Celegence and their team of experts to anyone facing resource challenges or regulatory hurdles.”
Miriam Tenorio – Vice President, Marketing,
“I am very happy with the service received and with the finished Clinical Evaluation Report, which was exactly what we needed. The fact that you have a dentist on staff made the whole document authoring process work very well.”
Ben Jaggers – Managing Partner,
“Our experience working alongside Celegence, from Account Manager through to Leadership, has been uniformly excellent! We would like to thank them all, in particular the SMEs for their support of critical regulatory compliance activities. We are truly impressed with Celegence’s flexible approach and highly knowledgeable team.”
Matt Garrity – Director of Quality,
“We had a very good experience working alongside the Celegence medical device services team when drafting our clinical evaluation processes, and truly appreciate their highly professional and cooperative global regulatory experts. They took great care in understanding our CER/CEP and PSUR submission requirements.”
Marcel Borger – VP Quality & Regulatory Affairs,