At Fuerst Ittleman it is our goal to seamlessly merge our clients' business plans with the complex web of regulations imposed by the Food & Drug Administration ( FDA ), the United States Department of Agriculture ( USDA ) including the National Organic Program (NOP) and US Customs Border Patrol ( Customs ). The attorneys at Fuerst Ittleman have the knowledge to help guide clients through this system of laws, helping them navigate the global marketplace with ease.
Timing is everything. FI understands that clients are looking for quick action and personal attention. FI attorneys work with the client to meet critical deadlines. FI represents clients before the Food and Drug Administration in matters concerning:
- Food & Dietary Supplements
- Medical Devices & Investigational Device Exemptions (IDE)
- Pharmaceuticals & OTC Drugs
- Biotechnology
- Animal feed/Animal Drugs
- Cosmetics
- Electronic Radiation Products
- Human Tissue Issues/Stem Cells
- USDA Regulation and Organic Programs
- Establishment Registration
- GMP Requirements & SOPs
- Product Development Protocols & Substantiation Files
- Adverse Event Reporting
- Quality Systems (QSR)
- Health Claims & Structure/Function Claims
- Advertising Claims
- Ingredient Evaluations
- New Dietary Ingredient Submissions
- GRAS Determinations and Petitions
- Pre-Investigative New Drug (IND) and INDs
- Onsite Inspections
- FDA Warning Letters & 483s
- Injunctions
- Customs’ Detentions and Refusals,
- Customs’ penalties
- Import Alerts
- Product recalls
- Product Importation and Exportation
- Imports for Export
- Bioterrorism Act
- Criminal Enforcement and Prosecution Defense
From ideation to aftermarket, FI‘s regulatory counsel are there for support regardless of the objective. The FI philosophy is to be part of the client’s team. FI’s attorneys and consultants listen to clients’ goals and seek out creative and effective ways maximize the return on the client’s investment (ROI). FI attorneys draw from a variety of backgrounds: some have worked for the government agencies, others have honed their legal skills as in-house counsel to regulated corporations, and yet others have spent years in the courtroom gaining valuable litigation experience and successfully representing food and drug clients in actions against the FDA and other regulatory agencies all over the United States.
For more information, please contact Fuerst Ittleman at contact@fuerstlaw.com
