Regulatory clarity fromthoughttofinish

Regulatory Affairs Solutions

To approval and beyond.

In the complex life sciences landscape, where innovation meets regulation, a trusted regulatory partner is paramount.

ELIQUENT is the singular regulatory resource that clients around the world trust. Our unique platform goes beyond traditional consulting to deliver end-to-end solutions. ELIQUENT is more than a service provider—we are your strategic partner in regulatory success.

With a deep understanding of the regulatory landscape, we work as an extension of your team, offering proactive solutions that streamline your path to approval and beyond. Our premier team of regulatory experts have served in senior positions at global regulatory authorities and throughout industry. This rare blend of perspectives developed as leaders in both the public and private sectors enables us to deliver valuable insight throughout the product lifecycle.

No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock success.

Guided by decades of regulatory and clinical experience, and firmly grounded in the principles of public health, ELIQUENT’s team of regulatory experts is unmatched.

Clients count on us to provide objective advice and valuable insight throughout the product lifecycle. As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized experts provide both strategic direction and hands-on execution services to to support clients from the earliest phases of development to post-approval regulatory support.

Pipeline Review & Optimization

Our team of regulatory experts evaluate and prioritize development pipelines to identify valuable portfolio opportunities and to understand and effectively manage regulatory risks.

CMC Strategy

ELIQUENT’s highly experienced team of specialists strengthen CMC packages by facilitating risk-based evaluations that enable effective design and implementation strategies.

Clinical Programs

With decades of hands-on experience, ELIQUENT professionals provide best-in-class scientific and regulatory guidance on nonclinical, pre-clinical, and clinical programs across all therapeutic areas.

Regulatory Submissions

ELIQUENT applies extensive regulatory perspective to develop and implement actionable strategies that optimize a product’s regulatory submission and enhance agency interactions.

Pathway Solutions

ELIQUENT experts work with companies to develop comprehensive regulatory strategies that take into account special designation eligibility and the pathway selection for a successful result.

Marketing, Promotion & Labeling

Our team of skilled advisors provide specialized support and strategic direction on labeling requirements, promotional materials, and marketing programs.promotional materials, and marketing programs

Regulatory Communications

ELIQUENT’s team of respected professionals bring an unmatched level of credibility and trust when interacting with global regulators and guiding companies on the regulatory pathway.

Lifecycle Support

ELIQUENT’s integrated solutions equip innovators with strategic insight and actionable strategies that span the product lifecycle and unlock regulatory success.

300+ years of collective FDA experience

Over 160 INDs submitted with a 98% success rate.

Submitted over 50 applications for breakthrough therapies.

Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists set the standard for regulatory consulting excellence. 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 the regulators and when navigating today’s evolving regulatory environment.

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 in the following markets specialties:

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.

Our team of regulatory and clinical experts apply their specialized skill-set to move complex therapies through the regulatory process to manufacturing and beyond.

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

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.

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.

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.

ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill across markets, pathways, and global regulations. ELIQUENT’s specialized solutions showcase our collective capabilities and combined expertise. Together, we create a full-service model that equips clients with a premier regulatory resource.

Market Solutions

Guided by decades of regulatory and clinical experience, our premier team of life science experts have the specialized skills to assist clients across therapeutic areas, modalities and markets.

Market Solutions

Pathway Solutions

As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. Clients turn to our team for strategic direction and hands-on execution services that support the earliest phases of development to post-approval and beyond.

Pathway Solutions

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.

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 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 >>

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

From the earliest phases of innovation through regulatory submissions, to post- approval support, our robust blend of technical skill and clinical expertise guide companies to approval and beyond.

With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized pharmacovigilance solutions empower companies to operate with confidence.

Our team of highly specialized quality & compliance experts build customized solutions that equip companies with best-in-class strategic support, technical expertise, and project-based solutions.

ELIQUENT’s Remediation Solutions address challenges head-on, providing the expert guidance life science innovators need to bring your operations back into compliance and securing your path forward.

Whether you need a team of one or 100+, ELIQUENT’s talent solutions gives you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.

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

THOUGHT LEADERSHIP

Quality Systems in Drug Development

Read Steven Bowen, Ph.D.’s article in the Journal of Pharmaceutical Sciences.

Read more

Case Study: ELIQUENT Outcomes

Global regulatory strategy for immunology company to regulatory success.

SOLUTIONS

Pharmacovigilance & Risk Management Solutions

Explore ELIQUENT’s PV & Risk Management Solutions

Pharmacovigilance & Risk Management

QMSR Solutions

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

QMSR Solutions

Ready for regulatory clarity? Contact us.