Your FDA Law Team
Rick D. Quinn
FDA Regulatory Attorney
California Business Lawyer to
FDA Regulated Firms
Proven Track Record
17+ years of successful FDA
regulatory outcomes.
Warning Letter Resolution
Consistent success resolving FDA enforcement
actions.
Import Alert Expertise
Documented success obtaining FDA
Import Alert removals.
CBP Penalty Mitigation
Multiple mitigations of six-figure customs
penalties to zero liability.
Global Experience
Clients from 50+ countries
successfully entering U.S. markets.
California Expertise
Knowledge of California-specific
regulatory requirements.
Experienced California Lawyer Serving International Clients in FDA-Regulated Businesses
With over 20 years experience as a business lawyer, I provide specialized and comprehensive counsel to FDA-regulated companies navigating complex U.S. market entry requirements and compliance challenges. I represent startups, closely-held companies, large privately-held firms, and public companies across the full spectrum of FDA-regulated industries. I focus on FDA egulatory law, international trade compliance, and their respective implications for business, allowing me to provide specialized expertise. My experience with FDA enforcement actions, import compliance, and California regulatory requirements enables me to provide strategic counsel that protects your business while achieving your market objectives. Whether you’re facing an FDA Warning Letter, dealing with detained products at U.S. Ports of Entry, or planning to enter the U.S. market, I provide the focused expertise and proven results your FDA-regulated business needs.
As a California Business Attorney focused on FDA-regulated businesses, I have successfully represented hundreds of clients operating from more than 50 countries, providing:
- U.S. market entry strategies for international companies
- Fractional In-House Counsel
- FDA compliance programs for California-based businesses
- Cross-border regulatory compliance solutions
- International supply chain regulatory risk management
Industries I serve
Food &
Beverage
- Importers and manufacturers
- Distributors and retailers
- Online platforms and brand owners
Dietary
Supplements
- Contract manufacturers and formulators
- New Product Development and Design
- Labeling & Advertising Claims Developers
Cosmetics &
Personal Care
- Cosmetics importers & manufacturers
- Social Media Marketers & Platform Sellers
- Product Formulators & Advertisers
Pharmaceuticals
& Medical Devices
- Drug manufacturers and importers.
- Medical device companies.
- Biotech and pharmaceutical startups.
We defend your
rights against
FDA so you can
focus on your
business
We know dealing with FDA can be difficult and challenging
You deserve expert advice at a fair price. When you partner with us, you leverage our decades of experience to get the better outcome quickly.
What Clients
Say
A wealth of knowledge regarding the importation of FDA-regulated materials and would prove to be a valuable asset to any company in need of assistance in this area.
The team helped us with our exportation to USA. Their knowledge and understanding in FDA requirements and regulations was essential part of it. Thank you.
A wealth of knowledge regarding the importation of FDA-regulated materials and would prove to be a valuable asset to any company in need of assistance in this area.
The team helped us with our exportation to USA. Their knowledge and understanding in FDA requirements and regulations was essential part of it. Thank you.
A wealth of knowledge regarding the importation of FDA-regulated materials and would prove to be a valuable asset to any company in need of assistance in this area.
The team helped us with our exportation to USA. Their knowledge and understanding in FDA requirements and regulations was essential part of it. Thank you.