Empowering your
path to possible

Regulatory and clinical solutions to advance the life sciences lifecycle

We help life science innovators turn meaningful possibility into measurable progress. Our integrated team of proven regulatory and clinical experts ensures you have the right guidance and executional power to move your science forward with confidence.

We provide capital-efficient, fit-for-purpose solutions that scale with your evolving needs and empower your breakthrough ideas to become life-changing realities for the people who need them most.

Explore the Power of a Regulatory Partnership

We unite trusted regulatory and clinical leaders across our family of companies to help you seamlessly move your clinical and commercial journeys forward with purpose and precision.

Regulatory Services

Regulatory Advising and FDA Liaisons/US Agent

Turning innovative client assets into impactful therapies

Our experienced team delivers highly strategic regulatory advice and US agent/FDA Liaison services. We create regulatory opportunities throughout the product lifecycle and engage with FDA and global health authorities across therapeutic areas and technologies.
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Commercial Regulatory and MLR Review for Advertising and Promotions

Shaping strategy, inspiring confidence

We collaborate with a cross-functional team on target product profiles and key claims. We provide strategic guidance and review external scientific presentations and advertising and promotional materials.
See Commercial Regulatory Services

Regulatory, Scientific, and Medical Writing

Translating medical data into momentum

From commercial pre-launch and beyond, our expert medical and scientific writers craft strategic, message-driven clinical and nonclinical documents to support INDs and NDA, BLAs, and MAAs. We also author submission-ready publications, scientific communications, and product monographs.
See Medical Writing Services

Submissions to Health Authorities

Delivering FDA filings with 
precision

Our Operations and Submissions experts manage FDA filings through an approved gateway and validated eCTD software—submitting INDs, NDAs/BLAs, and promotional materials with confidence. We also build global eCTD applications to support filings throughout the rest of the world.
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Complement Your Clinical Development and Business Operations

We believe operational complexity shouldn’t stand in the way of scientific progress. Our expert medical advisors, clinical development leaders, and clinical business operations specialists provide life sciences companies with the confidence to navigate the U.S. and global regulatory landscape.

Clinical Operations

Clinical Development Operations

Overseeing end-to-end clinical trial execution

Our global experience across therapeutic areas ensures that we can address your unique challenges—whether it’s optimizing study designs, navigating complex clinical trials, enhancing operational efficiencies, or filling gaps in your current team. With deep-rooted clinical operations expertise, we provide seamless support for your full development program.
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Clinical Business Operations

Maximizing value and minimizing delays with strategic outsourcing

From managing CRO bids to aligning supply chains and securing risk coverage, we help you protect resources and control costs to keep clinical programs on track.
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Ask how we can help advance your science

Learn more about our clinical and regulatory capabilities

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