ELIQUENT brings clarity to regulatory complexity. We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products.

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.

Explore Solutions

Pathway Solutions

As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. Our highly specialized experts provide both strategic direction and hands-on execution services to support clients from the earliest phases of development to post-approval regulatory support.

Learn More

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.

Learn More

Global Solutions

ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.

Learn More

Introducing

ELIQUENT Life Sciences

ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.

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.

ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to deliver objective, reliable guidance across the product lifecycle.

With decades of experience in senior positions at the FDA, EMA and throughout industry, ELIQUENT’s team of respected professionals brings unmatched expertise that companies need when working directly with regulators and navigating today’s evolving regulatory environment.

Our unique platform goes beyond traditional consulting to deliver full-service solutions that equip clients with a premier regulatory resource. Together, we redefine regulatory consulting with integrated solutions that unlock success and clear the path to better health.

Combined Qualifications.
Unmatched Expertise.

ELIQUENT Life Sciences is built on the foundation of five global life science consultancies. Working together as an aligned, coordinated regulatory team, ELIQUENT delivers comprehensive solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape.

This unprecedented assembly of regulatory experts enables a unique understanding of the life sciences industry and the unmatched expertise companies need when navigating today’s evolving regulatory environment.

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

PV + Safety

Quality & Compliance

Remediation Solutions

Talent Solutions

300+ years of collective FDA experience

Over 160 INDs submitted with a 98% success rate.

Submitted over 50 applications for breakthrough therapies.

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.

Learn More

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.

Learn More

Combination Products

Unlock the full potential of your combination product. Our team supports companies developing combination products with expert guidance throughout the product lifecycle.

Learn More

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.

Learn More

Expertise beyond borders. ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.

United States

ELIQUENT is a leading Food & Drug Administration (FDA) regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies.
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.

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 (EMA) and offers tailored solutions to ensure products meet and exceed the needs of our clients.

Asia

ELIQUENT offers regionally specialized solutions for the innovators across Asia. Our comprehensive solutions include expert guidance to innovators seeking approval in Japan, the third-largest pharmaceutical market in the world. Explore ELIQUENT’s solutions for clients in Japan’s life sciences market.

Explore ELIQUENT Japan >>

Ready for regulatory clarity? Contact us.