About Us
About Us

About Us

About Us

About Us

Regulatory clarity – from thought to finish

ELIQUENT Life Sciences delivers the answers and solutions global life sciences companies need to gain and maintain market authorization for their products.

We bring clarity to regulatory complexity with integrated regulatory, quality, and safety solutions that clients around the world trust.

Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.

From concept to commerce and strategy to execution, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. 

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.

Unmatched Expertise

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.

Unprecedented
Assembly

ELIQUENT’s foundation is built on an unprecedented assembly of regulatory leaders, industry experts, and technical specialists that collaborate seamlessly to deliver objective, reliable guidance across the product lifecycle.  Together, we bring clarity to regulatory complexity.

Full-Service
Support

ELIQUENT redefines regulatory consulting with a full-service approach tailored to the unique needs of the life sciences industry. Our unique platform and team of cross-functional experts deliver integrated solutions that equip clients with a premier regulatory resource.

John M. Taylor, Esq.

Head of Quality & Compliance Practice

Michele Dougherty, Ph.D.

Head, Regulatory Affairs Practice – U.S.

Sandra L. Kweder, M.D.

Regulatory Affairs Practice – U.S.

Shelley Gandhi

Pharmacovigilance & Safety Practice

Jamie Portnoff

Head of Pharmacovigilance & Safety Practice

David Elder

Quality & Compliance Practice

Mark D. Kramer

Regulatory Affairs Practice – U.S.

Donald D. Ashley, JD

Quality & Compliance Practice

Kalah Auchincloss, JD, MPH

Quality & Compliance Practice

Heather S. Rosecrans, F.R.A.P.S.

Regulatory Affairs Practice – U.S.

Shaun Stapleton

Regulatory Affairs Practice – Europe

Lorna Griffin

Head of Regulatory Affairs Practice – Europe
Expert Team

Global Solutions

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 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.

Explore ELIQUENT Japan >>

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.

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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300+ years of collective FDA experience

Over 160 INDs submitted with a 98% success rate.

Submitted over 50 applications for breakthrough therapies.

Pathway Solutions

ELIQUENT guides innovators on their path to approval and beyond.

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. ELIQUENT’s pathway solutions include:

Nonclinical Support

ELIQUENT’s customized support guides companies through crucial nonclinical phases with precision and expertise.

Preclinical Guidance

Our industry-recognize experts provide valuable insight that aligns with evolving global regulatory demands for long-term success.

Clinical Programs

With a proven track record of regulatory success, our team delivers objective guidance and unparalleled support for your complex clinical program.

Regulatory Submissions

ELIQUENT applies extensive regulatory experience to develop a regulatory approach that unlocks the full potential of your product’s journey. 

Post-Approval & Distribution

ELIQUENT evaluates and strengthens systems with an eye toward optimizing processes, mitigating risks, and creating a culture of compliance, while meeting business objectives.

Lifecycle Support

Our industry-recognized experts deliver valuable insight throughout the product lifecycle – this approach enables sustained post-market vigilance and a continued market positioning.

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

Information Sheet

Global Regulatory
Affairs Solutions

Download

Information Sheet

Quality &
Compliance Solutions

Info Sheet

NEWS & THOUGHT LEADERSHIP

ELIQUENT Acquires Azzur Consulting

Expands firm’s quality and compliance capabilities.

ELIQUENT Acquires Truliant Consulting

ELIQUENT Acquires Truliant Consulting

Expands firm’s pharmacovigilance platform.

Read more

INTEGRATED SOLUTIONS

PV & Risk Management Solutions

Explore ELIQUENT’s PV & Risk Management Solutions

CAPABILITIES SLIDES: Pharmacovigilance Solutions

QMSR Solutions

Explore ELIQUENT’s Quality Management System Regulation (QMSR) Solutions.

QMSR Solutions

Ready for regulatory clarity? Contact Us.