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

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,

“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,

“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,

Zap Surgical - Testimonial Celegence
Physis International - Testimonials Celegence

“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,

Transonic - Client Testimonial
Sensus Group - Global Life Science Regulatory

“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,

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,

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,

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,

Zap Surgical - Testimonial Celegence

“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,

Physis International - Testimonials Celegence

“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,

Transonic - Client Testimonial

“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,

Sensus Group - Global Life Science Regulatory

“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,