You can’t bolt MDR onto an old QMS and hope for the best. This episode focuses on the system-level changes needed to support MDR compliance.
About us
We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to unlock excellence throughout the product lifecycle. We are the convergence of regulatory expertise and technical capabilities across the therapeutic landscape. From thought to finish, concept to commerce, and strategy to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust. Together, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. Learn more at ELIQUENT.com
- Website
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https://eliquent.com/
External link for ELIQUENT Life Sciences
- Industry
- Professional Services
- Company size
- 501-1,000 employees
- Type
- Privately Held
- Specialties
- Regulatory Affairs, Lifecycle Solutions, Global support, and Advance Therapies
Employees at ELIQUENT Life Sciences
Updates
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Come win an iPad at the #VeevaSummit! Visit ELIQUENT Life Sciences at Booth #G16 and enter our raffle for your chance to win. One winner will be selected to receive the grand prize! Our team is preparing for the Veeva Systems R&D and Quality Summit and look forward to connecting and discussing the latest innovations in R&D. See you in Copenhagen!
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ELIQUENT Life Sciences’ CGT & ATMP Center of Excellence brings together cross-functional expertise across regulatory, quality, safety, manufacturing, and GxP implementation to support clients through the full lifecycle of advanced therapy development. Designed specifically for the unique complexity of cell and gene therapies, the COE provides an integrated model that helps organizations navigate evolving regulatory expectations, accelerate development timelines, and maintain the highest standards of quality and compliance — from early development through commercialization. The goal is simple: help innovative therapies reach patients faster, with clarity and confidence. Take a deeper dive into what the CGT & ATMP Center of Excellence means for advanced therapy programs: https://lnkd.in/eVnTC7JU
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Were here to support you through complex regulatory challenges. A clear, globally aligned CMC strategy is essential to ensure consistency, reduce uncertainty, and enable efficient execution across markets. Hear from our Regulatory Affairs Manager, Elena Barbara Z. in our recent CMC case study on how we supported a client with a clear global regulatory strategy. Learn how ELIQUENT can support your global CMC regulatory strategy: https://lnkd.in/etq4ujBR
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Meet the Pharmacovigilance team at the Veeva Summit! Swipe to hear what our team Emma-Jane Brookes, Vincenzo Pace, Saurabh Khurana, Indy Ahluwalia are most looking forward to at the Veeva Systems R&D and Quality Summit in Copenhagen, 28-29 May. Are you attending the summit? Come and meet our on-site team to learn how ELIQUENT Life Sciences can support your regulatory, quality, and safety consultancy needs. Learn more: https://eliquent.com/ #VeevaSummitEU
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Data integrity remains one of the most critical — and evolving — challenges across the pharmaceutical and medical product lifecycle. Join ELIQUENT Life Sciences experts Maya Davis, Steven Bowen, and Mariano Mattei for our free webinar, Why Data Integrity Matters: Essentials and Emerging Issues for Industry Webinar, as they explore the history of data integrity, regulatory expectations, CMC implications, and how today’s IT landscape is shaping compliance strategies. Register here: https://lnkd.in/g4p-F-85
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Meet us at Hole 13! Our #GxP team in Texas is excited to be at the ISPE SC Chapter Dallas Golf Tournament on May 19th as a hole sponsor. We’re looking forward to connecting with industry colleagues and enjoying a day on the course. See you there!
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Join ELIQUENT Life Sciences at the CINDE - Experts in FDI Life Sciences Forum Costa Rica on June 6 as our experts Silvia Vasquez, John Love, Bill Ditty, and José Zorrilla, MS connect with industry leaders to discuss the evolving future of life sciences across the region. From regulatory strategy and quality to global market readiness, our team is looking forward to engaging in conversations that are shaping innovation across the industry. If you’ll be attending, be sure to connect with the #ELIQUENT team throughout the event. We look forward to seeing you in Costa Rica.
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Navigating Quality-Related Complete Response Letters (CRLs) requires more than regulatory knowledge, it demands a proactive quality and development strategy that anticipates challenges before they impact approval timelines. We’re proud to share that ELIQUENT Life Sciences expert Grace McNally will be speaking at the 2026 American Association of Pharmaceutical Scientists (AAPS) | @aapscomms National Biotechnology Conference (NBC), taking place May 11–14 in San Diego, CA. Grace will join industry leaders to discuss lessons learned from quality-related CRLs and strategies for strengthening regulatory readiness across the development lifecycle. As novel therapies and complex biologics continue to evolve, conversations around quality, CMC readiness, and regulatory expectations are more important than ever. If you’re attending AAPS NBC, don’t miss the opportunity to connect with Grace.
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ELIQUENT Life Sciences reposted this
ELIQUENT Life Sciences representing at Food and Drug Law Institute (FDLI) annual conference in DC this week. Feeling reflective as this is my 10th year going to this conference since moving back to the east coast and 14 years with the company. It’s such a great conference with our partners, colleagues, and friends and a great community for networking in the regulated quality and compliance space.
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