We’ve sat where you sit. Now we stand beside you.
We built this firm around a simple idea: serve clients the way we always wanted outside counsel to serve us.
We’ve been the clinic office manager, navigating the complexity of a healthcare business from the inside. The regulator, deciding outcomes from inside a federal agency. The advisor, embedded in FDA-regulated companies trying to grow without breaking. That experience shapes everything about how we practice.
Whether advising clients on a single matter or as fractional general counsel, we focus on what we know. We keep relationships personal. We give advice that is practical, not theoretical. And we align legal strategy to your business goals.
We are not just outside counsel. We are your partners.
The insiders: Clinic Manager, Government Attorney, & In-House Counsel
Rafael “Ralph” Gaitan began his career as the Office Manager in his father’s medical practice, overseeing billing and licensing matters. Ann Marie Gaitan began hers inside CMS, as an attorney at the Office of Medicare Hearings and Appeals, later moving in-house within FDA-regulated companies.
We know how industry works and how regulators think because we lived it.
The depth: Forty years. Every angle.
From the clinic floor to the hearing room to the boardroom. Our firm is focused on the areas in which we have operator-level fluency, regulatory-insider knowledge, and internal stakeholder experience.
Medicare and Medicaid compliance. Healthcare licensing and billing. FDA regulatory strategy for medical devices, health & wellness tech, drugs, food, dietary supplements, and cosmetics. FTC advertising compliance. Healthcare fraud and abuse, and data privacy compliance programs. We provide specialized and fractional general counsel to highly regulated companies that need legal leadership embedded in the business.
We deliver outcomes, not just advice.
The partnership: We’re in it with you.
As entrepreneurs ourselves, we understand the drive to build something and the cost of being slowed down by legal complexity. That is why we practice differently.
We bring business acumen and specialized depth to every engagement. We find the practical solution that fits your business and deliver it clearly. No lengthy memos. No billable hours spent on analysis that leads nowhere.
Our clients need attorneys who can both spot the issue before it becomes a crisis, and step in during a crisis. Lawyers who know their business can confidently stand in front of the regulators on their behalf. And, counselors who understand their industry and can advise on new opportunities and negotiate commercial transactions.
Whether we are coming in to resolve a specific issue or are embedded into your company as factional general counsel, our team builds the compliance frameworks, governance structures, regulatory infrastructure and commercial playbooks your business needs to scale. Clients hire us to deliver outcomes, not just render advice.
We defend and protect what you have built.
Our Team, Your Partners
Rafael A. Gaitan, Esq.*, Founding & Managing Partner
Health Care Compliance, Corporate, and Administrative law
Direct: 786.440.8115 Email:rg@ragaitanlaw.com
Ann Marie Gaitan, Esq.*, Founding Partner
FDA, USDA, EPA and FTC Compliance
Direct: 786.440.8115 E-mail: amg@ragaitanlaw.com