Life Science Regulatory Consultants and Solutions

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.

Global Solutions

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.