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With deep experience in FDA consulting 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 - we've accomplished it all...
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 expedited reviews and orphan drugs, to regulating gene editing and AI/ML...
Find your policy solutions here
Latest Views
Federal Experience
Federal Experience
We publish regularly on health policy: read our Dec 2023 Milbank Quarterly essay on the Orphan Drug Act's 40th anniversary and our Feb 2023 Health Affairs Forefront views on mifepristone.
Federal Experience
Federal Experience
Federal Experience
We can help develop effective strategies to engage Federal agencies like HHS, FDA, NIH, CDC, ARPA-H and BARDA.
Diverse Clients
Federal Experience
Nonpartisan Expertise
Our clients include/have included Fortune 100 biopharmas, leading patient groups, advocacy coalitions, life science trade associations, and innovators in Europe, South Korea and Israel.
Nonpartisan Expertise
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
Nonpartisan Expertise
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?
Nonpartisan Expertise
Trusted Collaborators
Feel free to call or message with your health policy question. Let's discuss the issue and find some new approaches...