After spending more than two decades in the pharmaceutical industry with a diverse group of brand manufacturers, a large global consulting organization and the Food and Drug Administration (FDA), it was time to open my own solo law and advisory practice with a focus on clients involved with the FDA – Pistevo Law LLC. When translated from its Greek origin there are several meanings of "Pistevo:" to have faith in someone, to entrust, truth and conviction, persuasion and assurance. My logo for the new firm helps visualize the meaning of Pistevo Law LLC with a modern rendition of a flame symbolizing faith, trust, and zealousness. Why should you consider Pistevo Law LLC if you are interested in speaking with a food and drug law attorney? • Practical and reliable counsel and advice that considers all perspectives you are facing and delivered by someone who has walked in your shoes. • Honed by years of experience in and outside the FDA. • With flexible and creative models for pricing that are sensitive to your business but don’t compromise zealous counsel. PRACTICE AREAS • FDA procedure and policy • Regulatory exclusivities • All stages of product R&D, lifecycle management, regulatory submissions and product approvals • Preparing for FDA investigations, requests for records and inspections, and FDA inspection assessment • CGMP compliance and enforcement for drugs and dietary supplements • New product introduction, supply chain management and product lifecycle strategic planning • Legal and regulatory due diligence and regulatory related agreements • Market clearance for new dietary ingredients • Marketing requirements and approval processes for tobacco products • Compliance and enforcement for tobacco products • CBD policy and risk assessment President Abraham Lincoln once said a lawyer’s time and advice are his stock in trade. If I can help your business navigate FDA issues, please get in touch. Licensed in CA. Practice limited to federal law.