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With deep experience in FDA regulatory law and health policy consulting, we advise patient advocates, global life science and innovative emerging companies on product approvals and regulatory reforms, drafting and enacting Federal legislation, and securing funding or creating new P3s...
About Us
Find Your Policy Solutions
Find Your Policy Solutions
Find Your Policy Solutions
Since 2002, we've collaboratively developed creative life science, FDA and public health solutions for Fortune 100 and emerging companies, coalitions, and patient groups.
About Paul
Find Your Policy Solutions
Find Your Policy Solutions
Offering 30+ years of Federal health
policy and legislative insights, as former congressional committee staff, policy advisor, and leader of national FDA law and Federal affairs practices
What's New?
Find Your Policy Solutions
What's New?
See our views and opinions on the latest health policy developments - from disruptions in Federal funding and regulation, orphan drugs and expedited drug reviews, to regulating gene editing and AI/ML...
Find your policy solutions here
Latest Views
Read our Milbank Quarterly essays on FDA in the Trump Administration and the Orphan Drug Act's 40th anniversary or our Health Affairs Forefront essays on HHS Secretary Kennedy and vaccines and on mifepristone.
Federal Experience
We can help develop effective strategies to engage Federal agencies like HHS, FDA, NIH, CDC, ARPA-H and BARDA.
Diverse Clients
Nonpartisan Expertise
Our clients have included Fortune 500 and innovative startup biopharmas, leading patient groups, coalitions, life science trade associations, and innovators in Europe, South Korea and Israel.
Nonpartisan Expertise
Nonpartisan Expertise
Our solutions are grounded in sound policy, a clear understanding of the law, and the best clinical evidence - helping advance public health for all.
Trusted Collaborators
If your issue is at CMS or requires Federal lobbying, we know trusted consulting partners who are national experts in their domains.
Just Have a Question?
Feel free to call or message with your health policy question. Let's discuss the issue and find some new approaches...