Regulatory Clarity fromthoughttofinish
Integrated Solutions.
Full-Service Support
ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide a full-service engagement that delivers end-to-end support. No matter your pathway position, regulatory requirements, global market, or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.
Regulatory Affairs Solutions
PV+ Postmarket Surveillance
Quality & Compliance
Remediation Solutions
Talent Solutions
Unmatched Expertise
ELIQUENT is the singular regulatory resource that that clients around the world trust. No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.
Market Solutions
With a robust understanding of global regulatory requirements, ELIQUENT provides tailored solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape.
Our team of highly qualified experts bring decades of regulatory, quality, safety, and clinical experience across markets and therapeutic specialties.
Drugs & Biological Products
ELIQUENT’s team of experts provide strategic and technical guidance on drugs and biologics from product development to regulatory review and beyond post-market requirements.
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Advanced Therapies & CGTs
Our team of regulatory and clinical experts apply their specialized skill-set to move complex therapies through the regulatory process to manufacturing and beyond.
Medical Devices & Diagnostics
Leverage our team’s extensive experience as you navigate the process of bringing new devices and diagnostics to market and manufacturing them to quality standards.
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Combination Products
Unlock the full potential of your combination product. Our team supports companies developing combination products with expert guidance throughout the product lifecycle.
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Cosmetics
ELIQUENT’s knowledge and understanding of the evolving cosmetics regulatory landscape provides clients with a trusted partner when developing and commercializing cosmetic products in compliance with regulations.
Industry Due Diligence
ELIQUENT applies vast institutional knowledge to equip investors with the information needed to ensure life science transactions account for business objectives, regulatory risks, and the industry landscape.
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Expertise beyond borders. ELIQUENT Life Sciences delivers integrated regulatory, quality, and safety expertise to help life sciences companies bring innovative products to market and maintain compliance worldwide.
Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia. From early development strategy to post-market oversight, our solutions are designed to meet the unique regulatory, quality, and pharmacovigilance challenges faced by globally regulated companies.
United States
Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day. Learn More
Europe
The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency and offers tailored solutions to ensure products meet and exceed the needs of our clients.
Asia
ELIQUENT offers regionally specialized solutions for innovators across Asia. Our team of highly specialized experts partner with innovators to develop a synchronized, global go-to-market approach that unlocks the full potential of the Asia market and leverages the strategic advantages of Japan’s regulatory landscape.
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Global Market Expansion
ELIQUENT provides end-to-end solutions that support companies navigating complex global regulations. Whether launching a new product or expanding into new regions, ELIQUENT works with innovators to mitigate risks, streamline approvals, and maintain compliance across evolving regulatory landscapes.
United States
Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.
Our U.S. experts guide companies through FDA expectations across drugs, biologics, medical devices, and combination products. We provide hands-on support with:
QMSR/QSR compliance and inspection readiness
IND, NDA, BLA, and PMA strategy and submissions
Safety and pharmacovigilance system design and operations
Risk management, post-market surveillance, and enforcement response
Global Market Expansion
ELIQUENT provides end-to-end solutions that support companies navigating complex global regulations. Whether launching a new product or expanding into new regions, ELIQUENT works with innovators to mitigate risks, streamline approvals, and maintain compliance across evolving regulatory landscapes.
Your resource for regulatory clarity.
IQ Central is your resource for industry insights, expert perspectives, and valuable tools. Here, you’ll find a comprehensive collection of collateral, expert resources, and thought leadership designed to support your goals and keep you informed on the latest trends and help you navigate today’s regulatory landscape.
Resources
THOUGHT LEADERSHIP
Impact of R&D Quality Systems & Data Integrity in Drug Development
Read Steven Bowen, Ph.D.’s article in the Journal of Pharmaceutical Sciences.
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Case Study: Global Regulatory Solutions
Learn how ELIQUENT Japan guided a global immunology company to regulatory success.
Read moreSOLUTIONS
Regulatory Writing
Explore ELIQUENT’s Regulatory & Medical Writing Solutions.
Regulatory Writing Solutions