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.

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.

Date of application to the EU IVDR

26th May 2022

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Our Life Sciences Services

Regulatory Labeling

Supporting client requirements from creation to maintenance of global and local drug product labeling.

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Regulatory Intelligence Solutions

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

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MDR Compliance

Our innovative proprietary solution allows our expert medical writing team deliver clinical evaluation reports with enhanced efficiency and improved quality.

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Regulatory Operations Management

Managed regulatory operations related to publishing, submission and regulatory information management for reduced total cost of ownership.

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IDMP & Compliance Consulting

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

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Post Market Surveillance

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

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Medical Writing

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

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UDI Consulting

Manage, maintain, and distribute your product data with precision and efficiency.

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Why Use Celegence For Your Organization’s Needs?

MDR Regulatory Services Celegence USA

  • Whether you need support with labeling, publishing, or Regulatory Information Management, our teams have years of experience conducting these activities on behalf of global life sciences companies.
  • Our leadership has combined experience of 25+ years in the Pharmaceutical industry and 15+ years in Regulatory Affairs.

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  • Increased efficiency for your organization through flexible and scalable solutions.
  • Options for onshore and offshore model or fully offshore model based on team and project needs.
  • We support large, mid, and small size life sciences companies in the pharmaceutical, generics, biotech, and medical devices spaces.

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MDR Compliance - Life Science Celegence

  • Our Regulatory Intelligence team keeps our operational team up to date on global as well as country and region-specific requirements for different process areas.
  • We can help you make informed, proactive Regulatory Strategy decisions by leveraging our technology solution, SRI (Simplified Regulatory Intelligence).

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MDR Compliance - Life Science Celegence

  • Our leadership team has decades of experience setting up offshore infrastructure and helping organizations achieve cost efficiencies by setting up an offshore team extension.
  • We have the unique ability to scale up and down based on volume of work or forthcoming internal and regulation-driven requirements.

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Pharma and Medical Devices Regulatory Services - Celegence

  • We have established Standard Operating Procedures and SLAs, allowing our teams to ensure high quality and predictable work efficiency.
  • We define the scope at project outset with your team to set forth clear timelines, quality metrics, and escalation procedures up front make for effective project objectives completion tracking.

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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
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Resources

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Additional Information

Download the latest brochures of our capabilities and services.

Medical Device Services Brochure

Medical Device Services Brochure

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Pharmaceutical Services Brochure

Pharmaceutical Services Brochure

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In Vitro Diagnostics Regulatory Experts - Medical Devices Industry Celegence

In Vitro Diagnostic Services Brochure

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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.

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