FDA fluency at every critical turn.

When the stakes are high and the path unclear, life sciences leaders come to us. At Canal Row Advisors, we guide with fluency from decades inside the FDA and industry. From first filings to final approvals, we navigate the toughest challenges so your innovation can lead the way.

Strategy with laser focus

We bring structure to uncertainty, poise to pressure, and a plan to every pivotal moment.

Guidance, not guesswork

Move faster, smarter, and with confidence at every step.

Accelerate science. Decelerate risk

We drive breakthroughs to market with the precision that keeps progress moving.

Our Services

Clinical & Regulatory Strategy

We bring structure from the start, so your development program is executed with purpose and your FDA review is navigated with confidence.

Clinical Evidence Modernization

We guide your strategic use of RWD, RWE, AI, and innovative trial designs to accelerate patient-centric development.

Quality & Compliance

We help you manage your products and facilities to meet rigorous FDA quality and manufacturing standards.

Regulatory Policy

We shape your path through the shifting regulatory policy environment.

Advisory Services

We navigate a complex regulatory landscape to inform some of the most high-stakes decisions in the life science space.

Guided by experience

Driven by precision.

The Canal Row Advisors team is built from former FDA officials, industry veterans, and strategic minds who’ve been in the room when decisions mattered most. 

Team headshot

Thinh X. Nguyen

Thinh is a senior regulatory advisor with over 33 years of experience at the FDA, bringing deep expertise in medical devices, combination products, and regulatory policy to help clients navigate complex cross-Center regulatory programs and product classification issues.
Thinh X. Nguyen headshot

Robert Meyer, MD

Robert is a senior advisor with over 30 years of regulatory, industry, and academic leadership, specializing in drug development, product evaluation, and regulatory strategy.
Robert Meyer, MD headshot

John Jenkins, MD

John is a senior advisor with over 25 years of FDA leadership experience, specializing in drug regulation, innovative therapy reviews, and complex regulatory policy for biological products.
Dr. John Jenkins Headshot

Kalah Auchincloss, JD, MPH

Kalah is an expert in FDA regulation, policy, and compliance who has led major regulatory modernization initiatives and enforcement activities at the agency.
Kalah Auchincloss, JD, MPH headshot
Team looking at computer in meeting

The fastest path through the FDA is the one built by people who’ve been there.

Recent News, Publications and Upcoming Events

John Jenkins, MD, and Robert Meyer, MD, join Canal Row as Senior Advisors

September 28, 2026

Former FDA leaders join Canal Row as Senior Advisors, bringing decades of regulatory and clinical development expertise to the firm’s Advisory Services practice.

Rare Trials Summit

Sept 14-16, 2026

Join Elizabeth Duke as she helps attendees navigate the complexities of global regulatory interactions through a mock advisory meeting workshop.

Press Release – Former FDA and Industry Leaders Launch Canal Row Advisors to Provide Strategic Regulatory Guidance

October 9, 2025

Read the full press release to learn more about Canal Row Advisors' mission to provide clarity and confidence to life science leaders in a rapidly changing regulatory environment.

Contact Us

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